CONtrolled Focal Fibrous Band Release Method Study (CONFFIRM)

Revelle Aesthetics

Status: Completed

Conditions: Cellulite

Treatments: Device: Avéli device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04743635

CP-10472

Details and patient eligibility

About

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

Full description

Multi-center, single-arm clinical study to evaluate the safety and effectiveness of the Avéli device in reducing the appearance of cellulite.

Enrollment: 74 patients

Sex: Female

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Moderate to severe cellulite

Exclusion criteria

• Body Mass Index ≥30.0

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Device: Avéli device

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

Experimental group

Description:

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:

Device: Avéli device