CelluliteCONFFIRMNCT04743635
CONtrolled Focal Fibrous Band Release Method Study
A study testing Avéli device in people with Cellulite, run by Revelle Aesthetics, Inc at 9 sites in 2 countries.
Trial summary
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulite
- What is being tested?
- Avéli device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 7 Jan 2021to 4 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Moderate to severe cellulite
Who cannot join
- Body Mass Index ≥30.0
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Clinical Site #8
Chestnut Hill, Massachusetts, 02467
Clinical Site #2
Coral Gables, Florida, 33146
Clinical Site #3
Los Angeles, California, 90292
Clinical Site #1
Minneapolis, Minnesota, 55441
Clinical Site #5
San Diego, California, 92121
Clinical Site #4
San Francisco, California, 94102
Clinical Site #6
Shreveport, Louisiana, 71105
Australia2 sites
Clinical Site #7
Southport, Queensland, 4215
Clinical Site #9
Toowoomba, Queensland, 4350
About this study
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Read the detailed description
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
- Conditions
- Cellulite
- Being tested
- Avéli device
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avéli deviceDevice
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Avéli device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Mild (≤4 depressions)
- Moderate (5 to 9 depressions)
- Severe (≥ 10 depressions) PART B - Average depth of depressions
0 None
- Mild (1-2 mm)
- Moderate (3-4 mm)
- Severe (≥5 mm)
Measured: 3 months
Secondary outcomes (5)
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
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.
Measured: 3 months
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
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.
Measured: 12 Months
The Mean Change From Baseline to 12 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
- Mild (≤4 depressions)
- Moderate (5 to 9 depressions)
- Severe (≥ 10 depressions) PART B - Average depth of depressions
0 None
- Mild (1-2 mm)
- Moderate (3-4 mm)
- Severe (≥5 mm)
Measured: 12 months
The Percentage of Patients Satisfied With Their Results at 3 Months
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.
Measured: 3 month
The Number of Patients Satisfied With Their Results at 12 Months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start7 Jan 2021
- Primary completion14 Jun 2021
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CelluliteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants were treated with the Avéli device.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revelle Aesthetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. G. William Stevens, MD, Principal investigator, Marina Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743635
- Sponsor's protocol ID
- CP-10472
- Acronym
- CONFFIRM
- Status last verified
- Jun 2022
- First submitted
- 3 Feb 2021
- Last updated
- 6 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONtrolled Focal Fibrous Band Release Method Study
- ClinicalTrials.gov ID
- NCT04743635
- Acronym / sponsor ID
- CONFFIRM / CP-10472
- Conditions
- Cellulite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Revelle Aesthetics, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety and effectiveness of the Avéli medical device to reduce the appearance of cellulite.
Detailed description
Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants were treated with the Avéli device.
| Arm | Type | Receives |
|---|---|---|
| Targeted Verifiable Subcision (TVS) with the Avéli device, mITT | Experimental | Device: Avéli deviceModified 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 |
| Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in | Experimental | Device: Avéli deviceThe 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 |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Moderate to severe cellulite
Key exclusion criteria (1 listed)
- Body Mass Index ≥30.0
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avéli deviceMinimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks. | Device | Targeted Verifiable Subcision (TVS) with the Avéli device, Roll-in, Targeted Verifiable Subcision (TVS) with the Avéli device, mITT |
Primary outcome
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants
Time frame: 3 months
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)
5 secondary outcomes
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 3 Months
Time frame: 3 months
Percentage of Participants With Improvement as Assessed Using Global Aesthetic Improvement Scale (GAIS) at 12 Months
Time frame: 12 Months
The Mean Change From Baseline to 12 Months in Cellulite Severity Scale (CSS) Score for Participants
Time frame: 12 months
The Percentage of Patients Satisfied With Their Results at 3 Months
Time frame: 3 month
The Number of Patients Satisfied With Their Results at 12 Months
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Plan to share Executive Summary of Protocol. No formal, separate SAP for this study.
Related trials for Cellulite
Not yet recruiting
Pilot Study of Naringenin Beta Carotene Cream for Local Fat Reduction (SCULPT)
Thigh Cellulite
Active, not recruiting
Cyrolipolysis vs Cyrolipolysis and Subcision for Cellulite
Cellulite
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. G. William Stevens, MD principal investigator
Marina Plastic Surgery
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avéli device in people with Cellulite, run by Revelle Aesthetics, Inc at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Mean Change From Baseline to 3 Months in Cellulite Severity Scale (CSS) Score for Participants (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.