Trial Outcomes & Findings for Evaluation of the Use of the Renuvion APR System in the Labia (NCT NCT05323630)
NCT ID: NCT05323630
Last Updated: 2025-12-23
Results Overview
Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days and 180-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the labia. Change was assessed as success with success being the correct identification of treated labia images by at least 2 of the 3 reviewers.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Day 90, Day 180
Results posted on
2025-12-23
Participant Flow
There were no pre-assignments, but 7 subjects were treated with the APR-15-TP Handpiece and 3 of the subjects were treated with the Micro Handpiece launched after the study began.
Participant milestones
| Measure |
Procedure With the Renuvion APR System in the Labia (APR-15-TP)
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure With the Renuvion APR System in the Labia (Micro)
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Use of the Renuvion APR System in the Labia
Baseline characteristics by cohort
| Measure |
Procedure With the Renuvion Micro System in the Labia
n=3 Participants
The labia procedure utilizing the Renuvion Micro system will be performed per the investigator's standard clinical practice.
|
Total
n=10 Participants
Total of all reporting groups
|
Procedure With the Renuvion APR System in the Labia
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice.
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=68 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=4 Participants
|
10 Participants
n=219 Participants
|
7 Participants
n=68 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=68 Participants
|
|
Age, Continuous
|
41 Years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
41 Years
STANDARD_DEVIATION 5.1 • n=219 Participants
|
41 Years
STANDARD_DEVIATION 4 • n=68 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
10 Participants
n=219 Participants
|
7 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=4 Participants
|
9 Participants
n=219 Participants
|
6 Participants
n=68 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=4 Participants
|
3 Participants
n=219 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=4 Participants
|
4 Participants
n=219 Participants
|
3 Participants
n=68 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=68 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=68 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=4 Participants
|
10 participants
n=219 Participants
|
7 participants
n=68 Participants
|
|
BMI
|
26.773 kg/m2
n=4 Participants
|
25.704 kg/m2
n=219 Participants
|
25.246 kg/m2
n=68 Participants
|
PRIMARY outcome
Timeframe: Day 90, Day 180Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days and 180-days post-treatment compared to baseline for each subject. Images were provided in a blinded and randomized order. Each blinded reviewer choose which set of images were the post-treated Renuvion images of the labia. Change was assessed as success with success being the correct identification of treated labia images by at least 2 of the 3 reviewers.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=14 Sets of B/A Images analyzed
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=6 Sets of B/A Images analyzed
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Evaluation of Change Between Baseline and Follow-up Images as Determined by a Masked, Qualitative Assessment of Photographs at 90-days and 180-days Post-treatment Compared to Baseline.
|
4 Sets of B/A Images analyzed
|
4 Sets of B/A Images analyzed
|
SECONDARY outcome
Timeframe: Day 180Analysis by anatomical measurements of the labia majora and minora at D180.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Analysis of Morphometric Labia Measurements at D180.
Arch of Labia Majora Day 180
|
10.8 cm
Standard Deviation 1.5
|
10.5 cm
Standard Deviation 0.9
|
|
Analysis of Morphometric Labia Measurements at D180.
Maximum Projection of Labia Majora Day 180
|
1.3 cm
Standard Deviation 0.3
|
0.9 cm
Standard Deviation 0.3
|
|
Analysis of Morphometric Labia Measurements at D180.
Arch of Labia Minora Day 180
|
8.7 cm
Standard Deviation 1.8
|
9.5 cm
Standard Deviation 1.0
|
|
Analysis of Morphometric Labia Measurements at D180.
Posterior Border of the Sulcus to the Fornix Day 180
|
0.9 cm
Standard Deviation 0.2
|
0.9 cm
Standard Deviation 0.1
|
|
Analysis of Morphometric Labia Measurements at D180.
Sulcus Length of Labia Majora (Posterior to Anterior Margins) Day 180
|
10.0 cm
Standard Deviation 0.6
|
10.5 cm
Standard Deviation 0.7
|
|
Analysis of Morphometric Labia Measurements at D180.
Introital Opening to Most Anterior Projecting Edge of the Labia Minora Day 180
|
1.3 cm
Standard Deviation 0.6
|
1.3 cm
Standard Deviation 0.8
|
|
Analysis of Morphometric Labia Measurements at D180.
Inter-Labial Sulcus Length Day 180
|
9.0 cm
Standard Deviation 1.0
|
7.6 cm
Standard Deviation 1.5
|
|
Analysis of Morphometric Labia Measurements at D180.
Resting Projection of Labia Minora Beyond Labia Majora Day 180
|
0.7 cm
Standard Deviation 0.5
|
0.8 cm
Standard Deviation 0.5
|
|
Analysis of Morphometric Labia Measurements at D180.
Maximum Projection of the Labia Minora Day 180
|
1.8 cm
Standard Deviation 0.8
|
1.8 cm
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Day 30, Day 90, Day 180MOTAKEF scale of labia protrusion, Type I-A: Less than 2cm, Type II-A: From 2cm to 4cm, Type II-C: From 2cm to 4cm, Type II-AI: From 4cm to 6 cm, Type VI-A: Greater than 6 cm. The greater the class the greater area of protrusion of labia minora past the labia majora. An "A" is added for asymmetry and a "C" for involvement of the clitoral hood.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Baseline · Type II-A: From 2cm to 4cm
|
6 Participants
|
3 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 30 · Type I-A: Less than 2cm
|
3 Participants
|
2 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 30 · Type II-A: From 2cm to 4cm
|
4 Participants
|
1 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 30 · Type II-AI: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 30 · Type VI-A: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 90 · Type I-A: Less than 2cm
|
3 Participants
|
2 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 90 · Type II-A: From 2cm to 4cm
|
4 Participants
|
1 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 90 · Type II-C: From 2cm to 4cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 180 · Type I-A: Less than 2cm
|
5 Participants
|
2 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 180 · Type II-A: From 2cm to 4cm
|
2 Participants
|
1 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 180 · Type II-C: From 2cm to 4cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 180 · Type II-AI: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Baseline · Type II-C: From 2cm to 4cm
|
1 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Baseline · Type II-AI: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Baseline · Type I-A: Less than 2cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Baseline · Type VI-A: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 30 · Type II-C: From 2cm to 4cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 90 · Type II-AI: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 90 · Type VI-A: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Labia Protrusion (Distance of the Lateral Edge of the Labia Minora From That of the Labia Majora Rather Than the Introitus) at Baseline, D30, D90, and D180.
Day 180 · Type VI-A: Greater than 6 cm
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30, Day 90, Day 180Hipertrofia de Ninfas scale of hypertrophy; Type I (Less than 2cm), Type II (2-4cm), Type III (4-6cm), Type IV (\<6cm). The lower the type the better the outcome.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Baseline · Type VI: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 30 · Type I: Less than 2cm
|
3 Participants
|
2 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 30 · Type II: From 2cm to 4cm
|
4 Participants
|
1 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 30 · Type III: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 30 · Type VI: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 90 · Type I: Less than 2cm
|
2 Participants
|
2 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 90 · Type II: From 2cm to 4cm
|
5 Participants
|
1 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 90 · Type III: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 90 · Type VI: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 180 · Type I: Less than 2cm
|
5 Participants
|
2 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 180 · Type II: From 2cm to 4cm
|
2 Participants
|
1 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 180 · Type III: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Day 180 · Type VI: Greater than 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Baseline · Type III: From 4cm to 6 cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Baseline · Type I: Less than 2cm
|
0 Participants
|
0 Participants
|
|
Analysis of Hypertrophy of the Labia Minora (Hipertrofia de Ninfas) at Baseline, D30, D90, and D180
Baseline · Type II: From 2cm to 4cm
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 180The subjects completed a Patient Satisfaction Questionnaire (PSQ) at the Day 180 follow-up visit. The subject completed this assessment while referring to baseline photos, current photos, and a hand mirror.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Do you notice improvement in how your labia look? : Yes
|
7 participants
|
3 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Characterize Satisfaction With Procedure - Satisfied (Very, Satisfied, or Slightly)
|
6 participants
|
3 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Recommend Procedure To Friends and Family Members - Yes
|
6 participants
|
3 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Improvement noticed - Closer together
|
1 participants
|
1 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Improvement noticed - Improvement in loose skin
|
4 participants
|
3 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Improvement noticed - Less sagging skin
|
3 participants
|
3 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Improvement noticed - Majora seem smaller-Right Minora seems same or only slight improvement
|
1 participants
|
1 participants
|
|
The Subject Will Complete a Patient Satisfaction Questionnaire (PSQ) at the Day 180 Follow-up Visit.
Improvement noticed - Smoother skin texture
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180During study treatment, the subject's pain levels were monitored using the 11-point Numeric Rating Scale (NRS). The average pain score for the entire region treated was recorded. Pain scores will be recorded at all follow-up visits. NRS 11-point Scale where 0 is no pain and 10 is most pain.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Baseline
|
0.3 Score on a Scale
Standard Deviation 0.8
|
0.0 Score on a Scale
Standard Deviation 0.0
|
|
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Day 1
|
4.1 Score on a Scale
Standard Deviation 2.5
|
2.3 Score on a Scale
Standard Deviation 2.1
|
|
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Day 14
|
3.7 Score on a Scale
Standard Deviation 3.4
|
4.0 Score on a Scale
Standard Deviation 1.0
|
|
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Day 30
|
1.6 Score on a Scale
Standard Deviation 1.8
|
2.0 Score on a Scale
Standard Deviation 0.0
|
|
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Day 90
|
0.1 Score on a Scale
Standard Deviation 0.4
|
0.0 Score on a Scale
Standard Deviation 0.0
|
|
During Study Treatment, the Subject's Pain Levels Will be Monitored Using the 11-point Numeric Rating Scale (NRS).
Day 180
|
0.0 Score on a Scale
Standard Deviation 0.0
|
0.0 Score on a Scale
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Day 30, Day 90, Day 180The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, completed a bilateral GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 30 · Worse
|
0 Participants
|
0 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 30 · No Change
|
2 Participants
|
0 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 30 · Improved, Much Improved, Very Much Improved
|
5 Participants
|
3 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 90 · Worse
|
0 Participants
|
0 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 90 · No Change
|
1 Participants
|
0 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 90 · Improved, Much Improved, Very Much Improved
|
6 Participants
|
3 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 180 · Worse
|
0 Participants
|
0 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 180 · No Change
|
0 Participants
|
0 Participants
|
|
The Principal Investigator, Sub-investigator or Qualified Clinician Delegated by the Principal Investigator, Will Complete a Bilateral Global Aesthetic Improvement Scale (GAIS) Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 180 · Improved, Much Improved, Very Much Improved
|
7 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 30, Day 90, Day 180The subject completed a GAIS assessing overall aesthetic improvement in the treatment area at Day 30, Day 90, and Day 180 post-treatment. Global Aesthetic Improvement Scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 90 · No Change
|
0 Participants
|
1 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 30 · No Change
|
2 Participants
|
1 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 30 · Improved, Much Improved, Very Much Improved
|
5 Participants
|
2 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 90 · Worse
|
0 Participants
|
0 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 90 · Improved, Much Improved, Very Much Improved
|
7 Participants
|
2 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 180 · Worse
|
0 Participants
|
0 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 180 · No Change
|
1 Participants
|
0 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 30 · Worse
|
0 Participants
|
0 Participants
|
|
The Subject Will Complete a GAIS Assessing Overall Aesthetic Improvement in the Treatment Area.
Day 180 · Improved, Much Improved, Very Much Improved
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 90, Day 180Female Sexual Function Index (FSFI) evaluation which measures desire, arousal, lubrication, orgasm, satisfaction, and pain, was administered at baseline, Day 90, and Day 180; 5 Answers available per question. The individual domain scores and full-scale score of the FSFI are derived by the computational formula. Response options for questions were: 0=no sexual activity, 5=almost always or always, 4=most times (more than half the time), 3=sometimes (about half the time), 2=a few times (less than half the time), 1=almost never or never. Individual domain scores are obtained by adding the scores of the individual items that comprise the domain and multiplying the sum by the specified domain factor. The full-scale score is obtained by adding the six domain scores with potential ranges from 2 to 36.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia.
FSFI Baseline
|
24.45 Score on FSFI Scale (Range 2 - 36)
Standard Deviation 1.1
|
25.17 Score on FSFI Scale (Range 2 - 36)
Standard Deviation 0.5
|
|
The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia.
FSFI Day 90
|
24.45 Score on FSFI Scale (Range 2 - 36)
Standard Deviation 1.1
|
27.89 Score on FSFI Scale (Range 2 - 36)
Standard Deviation 1.3
|
|
The Subject Will Complete a Female Sexual Function Index (FSFI) to Assess the Sexual Function to Evaluate the Impact of Treatment to the Labia.
FSFI Day 180
|
29.49 Score on FSFI Scale (Range 2 - 36)
Standard Deviation 0.8
|
26.51 Score on FSFI Scale (Range 2 - 36)
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Baseline, Day 90, Day 180The Genital Appearance Satisfaction (GAS) scale was used to assess the satisfaction of subjects with their genital appearance following treatment to the labia at baseline, Day 90, and Day 180. The higher the GAS score reveals the greater dissatisfaction. Response options for each section of questions were Never (score 3), Sometimes (score 2), Often (score 1), Always (score 0). Question response values were added together for a final score for each participant. The best response would be 0 (no dissatisfaction). The worse response would be 30 (dissatisfaction across all questions).
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits
Genital Appearance Satisfaction Baseline
|
18.57 Score on GAS Scale (0 -30 Range)
Standard Deviation 0.6
|
22.33 Score on GAS Scale (0 -30 Range)
Standard Deviation 0.5
|
|
The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits
Genital Appearance Satisfaction Day 90
|
9.14 Score on GAS Scale (0 -30 Range)
Standard Deviation 0.5
|
12.33 Score on GAS Scale (0 -30 Range)
Standard Deviation 0.4
|
|
The Subject Will Complete a Genital Appearance Satisfaction (GAS) at Baseline, 90, and 180-day Follow-up Visits
Genital Appearance Satisfaction Day 180
|
9.86 Score on GAS Scale (0 -30 Range)
Standard Deviation 0.6
|
10.67 Score on GAS Scale (0 -30 Range)
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Post-Treatment, Day 1, Day 14, Day 30, Day 90, Day 180Subjects report the number of days until they feel comfortable returning to sex.
Outcome measures
| Measure |
Procedure with the Renuvion APR System in the labia (APR-15-TP)
n=7 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure with the Renuvion APR System in the labia (Micro)
n=3 Participants
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Analysis of Days Until Subject Was Comfortable Returning to Sex.
|
35.7 Days
Standard Deviation 26
|
21.7 Days
Standard Deviation 8.02
|
Adverse Events
Procedure With the Renuvion APR System in the Labia (APR-15-TP)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Procedure With the Renuvion APR System in the Labia (Micro)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Procedure With the Renuvion APR System in the Labia (APR-15-TP)
n=7 participants at risk
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The APR-15-TP Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
Procedure With the Renuvion APR System in the Labia (Micro)
n=3 participants at risk
The labia procedure utilizing the Renuvion APR system will be performed per the investigator's standard clinical practice. The Micro Handpiece was used in this group.
Renuvion APR System: The Apyx Medical Corporation Renuvion/J-Plasma helium plasma family of products has received FDA clearance under 510(k) numbers K191542, K192867 for the cutting, coagulation, and ablation of soft tissue.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Crepitus (ETE)
|
100.0%
7/7 • Number of events 7 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
100.0%
3/3 • Number of events 3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Bruise (ETE)
|
28.6%
2/7 • Number of events 2 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
33.3%
1/3 • Number of events 1 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Surgical and medical procedures
Edema (ETE)
|
100.0%
7/7 • Number of events 7 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
100.0%
3/3 • Number of events 3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Hypoesthesia/Numbness (ETE)
|
100.0%
7/7 • Number of events 7 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
100.0%
3/3 • Number of events 3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pain/Tenderness
|
85.7%
6/7 • Number of events 6 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
66.7%
2/3 • Number of events 2 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Pruritus/Itching (ETE)
|
14.3%
1/7 • Number of events 1 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
0.00%
0/3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Surgical and medical procedures
Wound
|
42.9%
3/7 • Number of events 3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
0.00%
0/3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
14.3%
1/7 • Number of events 1 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
0.00%
0/3 • 180 Days
An expected treatment effect (ETE) was defined as any typical treatment side-effect of Renuvion APR System of mild to moderate severity and lasting up to a typical maximum duration. An adverse event (AE) was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it is considered device-related by the investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed. The data produced by this sponsored study is the sole property of Sponsor. Sponsor must be provided with the opportunity to review all Investigator-prepared abstracts, publications, or presentations for a period of thirty (30) days for presentational materials and abstracts and forty-five (45) days for manuscripts.
- Publication restrictions are in place
Restriction type: OTHER