Trial Outcomes & Findings for CONtrolled Focal Fibrous Band Release Method Study (NCT NCT04743635)

Last Updated: 2023-06-06

Results Overview

The CSS includes a 6-point (range of 0-5) and will be determined by 3 independent, blinded physician assessors of images obtained before and 3-months after treatment. CSS Scale TOTAL CSS SCORE: = (PART A + PART B) - 1 PART A- Number of evident depressions 0 None 1. Mild (≤4 depressions) 2. Moderate (5 to 9 depressions) 3. Severe (≥ 10 depressions) PART B - Average depth of depressions 0 None 1. Mild (1-2 mm) 2. Moderate (3-4 mm) 3. Severe (≥5 mm)

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

3 months

Results posted on

2023-06-06

Participant Flow

74 was total enrollment: * 68 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, mITT * 6 participants allocated to Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-Ins. 6 training participants for 3 new Investigators.

Participant milestones

Participant milestones
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT N=68, included in the effectiveness analyses Allocation: non-randomized Intervention Model: Single Group Assignment	Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in N=6, excluded from the effectiveness analyses. The first two participants treated by three Investigators who never used the Avéli device were classified as roll-ins. Allocation: non-randomized Intervention model: Single group assignment
Overall Study STARTED	68	6
Overall Study COMPLETED	66	6
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT N=68, included in the effectiveness analyses Allocation: non-randomized Intervention Model: Single Group Assignment	Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in N=6, excluded from the effectiveness analyses. The first two participants treated by three Investigators who never used the Avéli device were classified as roll-ins. Allocation: non-randomized Intervention model: Single group assignment
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

CONtrolled Focal Fibrous Band Release Method Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device n=68 Participants Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.	Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in n=6 Participants Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.	Total n=74 Participants Total of all reporting groups
Age, Continuous	41.5 years STANDARD_DEVIATION 7.4 • n=5 Participants	40.8 years STANDARD_DEVIATION 8.1 • n=7 Participants	41.5 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	6 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	2 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants	4 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	6 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants	6 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment Australia	16 participants n=5 Participants	0 participants n=7 Participants	16 participants n=5 Participants
Fitzpatrick Skin Type I	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Fitzpatrick Skin Type II	19 Participants n=5 Participants	1 Participants n=7 Participants	20 Participants n=5 Participants
Fitzpatrick Skin Type III	24 Participants n=5 Participants	2 Participants n=7 Participants	26 Participants n=5 Participants
Fitzpatrick Skin Type IV	15 Participants n=5 Participants	1 Participants n=7 Participants	16 Participants n=5 Participants
Fitzpatrick Skin Type V	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Fitzpatrick Skin Type VI	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
BMI	24.9 kg/m^2 STANDARD_DEVIATION 2.6 • n=5 Participants	23.1 kg/m^2 STANDARD_DEVIATION 3.6 • n=7 Participants	24.8 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants
Laxity None	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Laxity Mild	37 Participants n=5 Participants	3 Participants n=7 Participants	40 Participants n=5 Participants
Laxity Moderate	30 Participants n=5 Participants	3 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: mITT

Outcome measures

Outcome measures
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=68 Participants Allocation: N/A, Intervention Model: Single Group Assignment
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants	1.5 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 3 months

Population: mITT

The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). The hierarchal endpoint is met if the lower bound of the 2-sided 95% confidence interval is greater than or equal to 0.6. Scale: -3:very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.

Outcome measures

Outcome measures
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=68 Participants Allocation: N/A, Intervention Model: Single Group Assignment
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months	95.6 Percentage of participants Interval 87.6 to 99.1

SECONDARY outcome

Timeframe: 12 Months

Population: mITT

The GAIS score was determined by blinded, independent evaluators. The GAIS scale counted if at least two of the three evaluators selected it, otherwise the median between the three was counted. A participant is considered improved if the GAIS assessment is improved (1), much improved (2) or very much improved (3). Scale: -3: very much worse, the treated area appearance is worse than before procedure, -2: much worse, the treated area appearance is significantly worse than before procedure, -1: worsened, the treated area appearance is slightly worse than before procedure, 0:no change, the treated area appearance is the same, +1: improved, noticeable improvement in appearance of the treated areas, but subtle, +2: much improved, significant improvement in appearance in the treated areas, +3: very much improved, optimal cosmetic result in the treated areas.

Outcome measures

Outcome measures
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=65 Participants Allocation: N/A, Intervention Model: Single Group Assignment
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months	93.85 percentage of participants Interval 84.99 to 98.3

SECONDARY outcome

Timeframe: 12 months

Population: mITT

Outcome measures

Outcome measures
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=65 Participants Allocation: N/A, Intervention Model: Single Group Assignment
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants	1.48 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: 3 month

Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 3 months. The outcome measure reports the percentage of participants satisfied with their results at 3 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses. The lower bound of the 2-sided 95% confidence interval had to be greater than or equal to 0.6.

Outcome measures

Outcome measures
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=68 Participants Allocation: N/A, Intervention Model: Single Group Assignment
The Percentage of Patients Satisfied With Their Results at 3 Months	72.1 percentage of participants Interval 59.9 to 82.3

SECONDARY outcome

Timeframe: 12 Months

Population: mITT

Participants were asked to rate their satisfaction with their results (from very satisfied to very dissatisfied) in an online questionnaire at 12 months. The outcome measure reports the number of participants satisfied with their results at 12 months. The Site was blinded to the questionnaire data. The sponsor was only unblinded after the data analyses.

Outcome measures

Outcome measures
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=65 Participants Allocation: N/A, Intervention Model: Single Group Assignment
The Number of Patients Satisfied With Their Results at 12 Months	45 Participants

Adverse Events

Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Targeted Verifiable Subcision (TVS) With the Avéli Device, mITT n=68 participants at risk Modified intent to treat population (mITT), n=68. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.	Targeted Verifiable Subcision (TVS) With the Avéli Device, Roll-in n=6 participants at risk Roll-in participants, n=6. Cellulite can be treated across thighs and buttocks. Minimally invasive procedure: Procedure for reducing cellulite.
Skin and subcutaneous tissue disorders Ecchymosis	86.8% 59/68 • Number of events 59 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	100.0% 6/6 • Number of events 6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Tenderness	51.5% 35/68 • Number of events 35 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	50.0% 3/6 • Number of events 3 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Pain	38.2% 26/68 • Number of events 26 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	33.3% 2/6 • Number of events 2 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Induration	36.8% 25/68 • Number of events 25 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	33.3% 2/6 • Number of events 2 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Incision site bleeding	16.2% 11/68 • Number of events 11 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
Nervous system disorders Numbness	17.6% 12/68 • Number of events 12 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Edema	11.8% 8/68 • Number of events 8 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	16.7% 1/6 • Number of events 1 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Fluid Discharge	8.8% 6/68 • Number of events 6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
Skin and subcutaneous tissue disorders Hemosiderin stain	7.4% 5/68 • Number of events 5 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Swelling	5.9% 4/68 • Number of events 4 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
General disorders Burning sensation	4.4% 3/68 • Number of events 3 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
Skin and subcutaneous tissue disorders Tingling	4.4% 3/68 • Number of events 3 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
Skin and subcutaneous tissue disorders Hyperpigmentation	4.4% 3/68 • Number of events 4 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	0.00% 0/6 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.
Skin and subcutaneous tissue disorders Contact Dermatitis	0.00% 0/68 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.	16.7% 1/6 • Number of events 1 • 1 year Adverse events (AEs) were defined as any undesirable medical occurrence providing the most comprehensive, real-world safety profile. This definition does not depend on a causal relationship with the device. At each visit, the investigator determined whether any AEs occurred. The Medical Monitor reviewed all adverse events and assigned the MedDRA lower-level term (LLT) codes. The Common Terminology Criteria for Adverse Events (CTCAE) scale grades 1-5 was used in CONFFIRM to describe AE severity.

Additional Information

Rachel Walsh, Senior Manager of Clinical Affairs

Revelle Aesthetics, Inc.

Phone: 6509634498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER