CONtrolled Focal Fibrous Band Release Method Study

NCT04743635 | Completed Results FDA Device

• 1 other identifier: CP-10472
• Study Type: interventional
• Target: 74
• Locations: 2 countries
• Sites: 9

Brief Summary

Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.

Conditions

Cellulite

Outcome Measures

Primary Outcomes (1)

• The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants

  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)

  3 months

Secondary Outcomes (5)

• Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months

  3 months

• Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months

  12 Months

• The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants

  12 months

• The Percentage of Patients Satisfied With Their Results at 3 Months

  3 month

• The Number of Patients Satisfied With Their Results at 12 Months

  12 Months

Study Arms (2)

Targeted Verifiable Subcision (TVS) with the Avéli device, mITT

EXPERIMENTAL

Modified intent to treat population (n=68). The modified intent to treat population was used to evaluate effectiveness. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks

Device: Avéli device

Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in

EXPERIMENTAL

The roll-in population (n=6) was excluded from the effectiveness analyses. For Investigators that have not previously performed an Avéli procedure, two (2) participants were classified as roll-in participants. The single procedure was conducted using the Avéli device for TVS. Cellulite can be treated on the thighs and buttocks

Device: Avéli device

Interventions

Avéli device DEVICE

Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.

Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in; Targeted Verifiable Subcision (TVS) with the Avéli device, mITT

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Moderate to severe cellulite

You may not qualify if:

• Body Mass Index ≥30.0

Sponsors & Collaborators

• Revelle Aesthetics, Inc: lead

Study Sites (9)

Clinical Site #3

Los Angeles, California, 90292, United States

Location

Clinical Site #5

San Diego, California, 92121, United States

Location

Clinical Site #4

San Francisco, California, 94102, United States

Location

Clinical Site #2

Coral Gables, Florida, 33146, United States

Location

Clinical Site #6

Shreveport, Louisiana, 71105, United States

Location

Clinical Site #8

Chestnut Hill, Massachusetts, 02467, United States

Location

Clinical Site #1

Minneapolis, Minnesota, 55441, United States

Location

Clinical Site #7

Southport, Queensland, 4215, Australia

Location

Clinical Site #9

Toowoomba, Queensland, 4350, Australia

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rachel Walsh, Senior Manager of Clinical Affairs
• Organization: Revelle Aesthetics, Inc.

rwalsh@revelleax.com

6509634498

Study Officials

• Dr. G. William Stevens, MD

  Marina Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants were treated with the Avéli device.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: January 7, 2021
• Primary Completion: June 14, 2021
• Study Completion: March 4, 2022
• Last Updated: June 6, 2023
• Results First Posted: June 6, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.

Locations

AU (2); US (7)