Trial Outcomes & Findings for Measuring Renuvion Soft Tissue Contraction Using Ultrasound (NCT NCT05968495)

Last Updated: 2025-02-03

Results Overview

Percentage of soft tissue contraction measured by an ultrasonographer on baseline ultrasound images compared to follow-up images to quantify the total amount of connective tissue contraction produced by the Renuvion treatment between the skin and the Scarpa's fascia. A negative value indicates greater tissue contraction, while a positive value indicates less tissue contraction.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Baseline, Day 365

Results posted on

2025-02-03

Participant Flow

Participant milestones

Participant milestones
Measure	Renuvion APR System Treatment Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Renuvion Soft Tissue Contraction Using Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renuvion APR System Treatment n=5 Participants Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48 Years STANDARD_DEVIATION 44 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
BMI	30.8 kg/m2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 365

Population: During this initial study treatment, the investigators realized the importance of fully expressing the helium from the tissue prior to taking the intra-operative measurements as residual helium expands the subcutaneous tissue, resulting in inaccurate contraction measurements. Due to this discovery and the subsequent change in treatment technique for the remaining subjects, the data for subject 001-BBJ is excluded from the intra-operative data tables and analysis.

Outcome measures

Outcome measures
Measure	Renuvion APR System Treatment n=4 Participants Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Analysis of Contraction From Baseline to Day 365	-44.0 percentage of contraction Standard Deviation 17.2

SECONDARY outcome

Timeframe: Day 365

Three experienced, blinded photographic reviewers performed a qualitative analysis/review of pre-treatment and post-treatment sets of images at 90-days, 180-days, 270-days, and 365-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 abdomen. Success was the correct identification of treated abdomen images by at least 2 of the 3 reviewers.

Outcome measures

Outcome measures
Measure	Renuvion APR System Treatment n=19 Sets of images analyzed Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
IPR Review	18 Correctly identified sets of images

SECONDARY outcome

Timeframe: Day 60, Day 90, Day 180, Day 270, Day 365

Population: One subject missed the D90 visit.

The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a PGAIS assessing overall aesthetic improvement in the treatment area.

Outcome measures

Outcome measures
Measure	Renuvion APR System Treatment n=5 Participants Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Physician Global Aesthetic Improvement Day 60 · Worse	0 Participants
Physician Global Aesthetic Improvement Day 60 · No change	0 Participants
Physician Global Aesthetic Improvement Day 60 · Improved, Much Improved, Very Much Improved	5 Participants
Physician Global Aesthetic Improvement Day 90 · Worse	0 Participants
Physician Global Aesthetic Improvement Day 90 · No change	0 Participants
Physician Global Aesthetic Improvement Day 90 · Improved, Much Improved, Very Much Improved	4 Participants
Physician Global Aesthetic Improvement Day 180 · Worse	0 Participants
Physician Global Aesthetic Improvement Day 180 · No change	0 Participants
Physician Global Aesthetic Improvement Day 180 · Improved, Much Improved, Very Much Improved	5 Participants
Physician Global Aesthetic Improvement Day 270 · Worse	0 Participants
Physician Global Aesthetic Improvement Day 270 · No change	0 Participants
Physician Global Aesthetic Improvement Day 270 · Improved, Much Improved, Very Much Improved	5 Participants
Physician Global Aesthetic Improvement Day 365 · Worse	0 Participants
Physician Global Aesthetic Improvement Day 365 · No change	0 Participants
Physician Global Aesthetic Improvement Day 365 · Improved, Much Improved, Very Much Improved	5 Participants

SECONDARY outcome

Timeframe: Day 60, Day 90, Day 180, Day 270, Day 365

Population: One subject missed the D90 visit.

The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area.

Outcome measures

Outcome measures
Measure	Renuvion APR System Treatment n=5 Participants Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Subject Global Aesthetic Improvement Day 60 · Worse	0 Participants
Subject Global Aesthetic Improvement Day 60 · No Change	0 Participants
Subject Global Aesthetic Improvement Day 60 · Improved, Much Improved, Very Much Improved	5 Participants
Subject Global Aesthetic Improvement Day 90 · Worse	0 Participants
Subject Global Aesthetic Improvement Day 90 · No Change	0 Participants
Subject Global Aesthetic Improvement Day 90 · Improved, Much Improved, Very Much Improved	4 Participants
Subject Global Aesthetic Improvement Day 180 · Worse	0 Participants
Subject Global Aesthetic Improvement Day 180 · No Change	0 Participants
Subject Global Aesthetic Improvement Day 180 · Improved, Much Improved, Very Much Improved	5 Participants
Subject Global Aesthetic Improvement Day 270 · Worse	0 Participants
Subject Global Aesthetic Improvement Day 270 · No Change	0 Participants
Subject Global Aesthetic Improvement Day 270 · Improved, Much Improved, Very Much Improved	5 Participants
Subject Global Aesthetic Improvement Day 365 · Worse	0 Participants
Subject Global Aesthetic Improvement Day 365 · No Change	0 Participants
Subject Global Aesthetic Improvement Day 365 · Improved, Much Improved, Very Much Improved	5 Participants

SECONDARY outcome

Timeframe: Day 180, Day 270, Day 365

The subject will complete a Patient Satisfaction Questionnaire (PSQ)

Outcome measures

Outcome measures
Measure	Renuvion APR System Treatment n=5 Participants Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Patient Satisfaction Characterize Satisfaction with Procedure: Satisfied (Very, Satisfied, or Slightly)	5 Participants
Patient Satisfaction Noticed improvement in how abdomen looks	5 Participants
Patient Satisfaction Recommends Procedure to Friends and Family Members	5 Participants
Patient Satisfaction Improvement Noticed: Improvement in wrinkles	2 Participants
Patient Satisfaction Improvement Noticed: Less sagging skin	5 Participants
Patient Satisfaction Improvement Noticed: Smoother skin texture	3 Participants

SECONDARY outcome

Timeframe: Day 0

Analysis of Energy per surface area was completed for all 5 subjects representing how much energy was delivered to each square centimeter of the abdomen's surface. The general pattern is that the energy per surface area decreases as the surface area of the abdomen increases. Analysis of energy delivered (kJ/cm2)

Outcome measures

Outcome measures
Measure	Renuvion APR System Treatment n=5 Participants Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Energy Delivered	0.037 kJ/cm2 Standard Deviation 0.012

Adverse Events

Renuvion APR System Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Renuvion APR System Treatment n=5 participants at risk Subjects are receiving treatment with the Renuvion APR system following power-assisted liposuction in the abdomen per investigator standard of care. Subjects may also have other body areas treated at the same time. Renuvion APR Handpiece: The Renuvion® APR (Apyx Plasma/RF) handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with a compatible generator for the delivery of radiofrequency energy and helium plasma for cutting, coagulation and ablation of soft tissue during open surgical procedures. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for cutting, coagulation or ablation of soft tissue during open surgical procedures. The compatible generators operate at an adjustable power of up to 40 W (expressed as 0 - 100% where 100% is 40 W) and provide an adjustable helium gas flow of 1 - 5 L/Min. APR Handpiece has a non-extendable electrode to generate helium plasma.
Surgical and medical procedures Seroma	60.0% 3/5 • Number of events 3 • 365 Days An expected treatment effect 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 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 Subcutaneous Nodule	60.0% 3/5 • Number of events 3 • 365 Days An expected treatment effect 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 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)	20.0% 1/5 • Number of events 1 • 365 Days An expected treatment effect 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 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

Christopher Nichols, MD

Pearl Plastic Surgery

Phone: 360-878-9300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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