Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000582651
Ethics application status
Approved
Date submitted
31/01/2023
Date registered
29/05/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
29/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cellulite treatment using the Aveli device: A pilot, feasibility trial.
Scientific title
Cellulite treatment for cosmetic thigh treatment in women with moderate-severe cellulite using the Aveli device: A feasibility trial.
Secondary ID [1] 308793 0
None
Universal Trial Number (UTN)
Trial acronym
The STRIVE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulite 328742 0
Condition category
Condition code
Skin 325747 325747 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 participants will undergo treatment on their thighs with optional buttock treatment with the Avéli procedure. Group 2 participants will undergo a combined procedure of Avéli with small volume fat grafting. The Avéli precision cellulite release device is a manual instrument intended to separate tissue (manner for the reduction in the appearance of cellulite). The Investigator will allocate participants to Group 1 or group 2 per the inclusion/exclusion criteria. Any candidates enrolled in Group 2 must have a suitable fat donor site. A minimum of 5 participants must be enrolled in each group.
Intervention code [1] 325245 0
Treatment: Devices
Comparator / control treatment
The study is non-comparative study and the two groups will be assessed independently. Group 1 will undergo cellulite treatment on their thighs with optional buttock treatment with the Avéli device. Group 2 will undergo the combined procedure of Avéli treatment for cellulite with small volume fat grafting on their thighs with optional buttock treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333596 0
Primary Safety endpoint: to evaluate the rate of serious adverse events related to the device or the procedure in either Study Group. The research staff will document any symptoms reported by patients throughout the study period, including the 24 hour post-procedure phone call and at the 7-Day, 1-Month and 3-Month post-procedure in-clinic visits. Adverse events will be assessed at each of the follow up visits. The investigators will physically evaluate the treated areas at all follow up visits and document any symptoms as adverse events or investigators safety findings.
Timepoint [1] 333596 0
Data will be collected at all participant visits in both study groups including procedure day and post procedure. The follow-up for both groups will be through 3-months. Data will be collected at all participant visits including procedure day and Days 1, 7, 30 and 90 post procedure.
Primary outcome [2] 333597 0
The primary feasibility endpoint for Group 1: Global Aesthetic Improvement Scale (GAIS) improvement is > 60% on thighs at 3 months. The proportion of participants with GAIS improvement (+1 or greater) as determined by one independent physician reviewer.
Timepoint [2] 333597 0
3 months post-procedure.
Primary outcome [3] 334368 0
The primary feasibility endpoint for Group 2: The ability to complete the Avéli procedure with fat grafting procedure within the context of one treatment session. Data will be collected on a procedure electronic case report form and procedure source worksheet which documents data regarding the successful completion of the procedure. The data will be entered into the electronic study database and the source worksheets are stored with the clinical practice study records.
Timepoint [3] 334368 0
A completion of procedure.
Secondary outcome [1] 417697 0
Mean change from baseline in the Cellulite Severity Scale (CSS) as determined by one independent physician reviewer.
Timepoint [1] 417697 0
3 months post-procedure.

Eligibility
Key inclusion criteria
1.Female 21-55 years
2.Moderate to severe cellulite on the thighs, or, if applicable buttocks
3.Minimum of 5 depressions on the thigh(s)
4.BMI < 35
Minimum age
21 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.In the last 12 months, underwent a cellulite treatment on the buttocks and/or thighs
2.Previous liposuction on the buttocks and/or thighs
3.Greater than 10% increase or decrease in body weight within the last six (6) months or any history of weight loss greater than 60 kg
4.Tattoo or former tattoo in the treatment area
5.Physician assessed severe skin laxity, flaccidity, and/or sagging in targeted cellulite treatment regions

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
Other
Other design features
The study is non-comparative study and the two groups will be assessed independently. It is a prospective, pilot trial. Both groups will undergo the Avéli procedure and will be followed for 3 months.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be performed on all enrolled participants for which the treatment with the investigational device was initiated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/01/2023
Date of last participant enrolment
Anticipated
Actual
3/05/2023
Date of last data collection
Anticipated
30/11/2023
Actual
29/11/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 39314 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 313009 0
Commercial sector/Industry
Name [1] 313009 0
Revelle Aesthetics Pty Ltd
Country [1] 313009 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Revelle Aesthetics Pty Ltd
Address
58 Gipps Street, Collingwood VIC 3066
Country
Australia
Secondary sponsor category [1] 314696 0
None
Name [1] 314696 0
Address [1] 314696 0
Country [1] 314696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312273 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 312273 0
Ethics committee country [1] 312273 0
Australia
Date submitted for ethics approval [1] 312273 0
07/11/2022
Approval date [1] 312273 0
06/12/2022
Ethics approval number [1] 312273 0
2022-11-1186

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

Contacts
Principal investigator
Name 124066 0
Dr Craig Layt
Address 124066 0
The Layt Clinic, 16 Harvest Ct, Southport QLD 4215
Country 124066 0
Australia
Phone 124066 0
+61 7 5597 4100
Fax 124066 0
+61 7 5587 6100
Email 124066 0
[email protected]
Contact person for public queries
Name 124067 0
Craig Layt
Address 124067 0
The Layt Clinic, 16 Harvest Ct, Southport QLD 4215
Country 124067 0
Australia
Phone 124067 0
+61 7 5597 4100
Fax 124067 0
+61 7 5587 6100
Email 124067 0
[email protected]
Contact person for scientific queries
Name 124068 0
Rachel Walsh
Address 124068 0
Revelle Aesthetics, Pty. Ltd., 58 Gipps Street, Collingwood, VIC, 3066
Country 124068 0
Australia
Phone 124068 0
+61 3 9419 7607
Fax 124068 0
Email 124068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be aggregated.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.