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A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants

Cellulite Clinical Trial

Official title:
A Single-Center, Prospective Study to Evaluate the Safety and Effectiveness of Multi-Treatment Regimen With Zeltiq Aesthetics, Inc. Rapid Acoustic Pulse (RAP)™ Device for the Improvement in the Appearance of Cellulite

Clinical Trial Summary

Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel. Rapid Acoustic Pulse (RAP) is an electrohydraulic (EH) device developed to improve the appearance of cellulite through microscopic disruption of the connection between the skin and underlying tissue leading to a reduction in the severity of dimples and ridges. The purpose of this study is to assess adverse events and effectiveness of RAP in adults seeking treatment of cellulite. RAP is an FDA approved device for the short-term improvement in the appearance of cellulite in the buttocks and thighs. Participants 18-50 years of age seeking treatment of cellulite will be enrolled. Up to 15 participants will be enrolled in the study at 1 site in the United States. Participants will receive 3 separate cellulite treatment sessions. Each treatment session will consist of RAP treatment delivered to bilateral thigh and/or buttock areas using the same treatment settings for both sides. The study duration is up to 72 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05664581
Study type Interventional
Source Zeltiq Aesthetics
Contact Alison Akbari
Phone 19252416297
Email clinicalstudy@pleasantonirc.com
Status Recruiting
Phase Phase 4
Start date December 14, 2022
Completion date April 30, 2024
View Details
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