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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04743635




Registration number
NCT04743635
Ethics application status
Date submitted
3/02/2021
Date registered
8/02/2021

Titles & IDs
Public title
CONtrolled Focal Fibrous Band Release Method Study
Scientific title
CONtrolled Focal Fibrous Band Release Method Study
Secondary ID [1] 0 0
CP-10472
Universal Trial Number (UTN)
Trial acronym
CONFFIRM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulite 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Avéli device

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

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


Treatment: Devices: Avéli device
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
The Percentage of Patients Satisfied With Their Results at 3 Months
Timepoint [4] 0 0
3 month
Secondary outcome [5] 0 0
The Number of Patients Satisfied With Their Results at 12 Months
Timepoint [5] 0 0
12 Months

Eligibility
Key inclusion criteria
* Moderate to severe cellulite
Minimum age
21 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Body Mass Index =30.0

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/03/2022
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Clinical Site #7 - Southport
Recruitment hospital [2] 0 0
Clinical Site #9 - Toowoomba
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
4350 - Toowoomba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Revelle Aesthetics, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. G. William Stevens, MD
Address 0 0
Marina Plastic Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Will post Protocol Executive Summary on June 14, 2022. It will be available indefinitely.
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04743635