Study Results
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View full resultsBasic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2021-01-07
2022-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Avéli 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
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
Avéli device
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Interventions
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Avéli device
Minimally invasive single procedure with the Avéli device for reduction in the appearance of cellulite in the thighs and buttocks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
55 Years
FEMALE
Yes
Sponsors
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Revelle Aesthetics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. G. William Stevens, MD
Role: PRINCIPAL_INVESTIGATOR
Marina Plastic Surgery
Locations
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Clinical Site #3
Los Angeles, California, United States
Clinical Site #5
San Diego, California, United States
Clinical Site #4
San Francisco, California, United States
Clinical Site #2
Coral Gables, Florida, United States
Clinical Site #6
Shreveport, Louisiana, United States
Clinical Site #8
Chestnut Hill, Massachusetts, United States
Clinical Site #1
Minneapolis, Minnesota, United States
Clinical Site #7
Southport, Queensland, Australia
Clinical Site #9
Toowoomba, Queensland, Australia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP-10472
Identifier Type: -
Identifier Source: org_study_id
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