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NCT01671839 · ClinicalTrials.gov registry record · NA
Study of the Cabochon System for Improvement in the Appearance of Cellulite
A NA study of Gynoid Lipodystrophy, sponsored by Merz North America.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 3
- Study locations
NCT01671839: Completed NA study of Gynoid Lipodystrophy, sponsored by Merz North America.
NCT01671839 is a NA study of Gynoid Lipodystrophy that has completed, run by Merz North America. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01671839, a NA study of Gynoid Lipodystrophy, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.
Primary Outcome
Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3
Conditions Studied
Interventions
- DEVICE Subcutaneous tissue release with the Cabochon System
Study Locations (3)
Louisiana
- The Coleman Center for Cosmetic and Dermatologic Surgery - Metairie
Maryland
- Maryland Laser Skin & Vein Institute - Hunt Valley
Massachusetts
- SkinCare Physicians - Chestnut Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT01671839 record still lists
NCT01671839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Gynoid Lipodystrophy appearing as the primary indexed condition, and to 1 intervention - of which Subcutaneous tissue release with the Cabochon System is the first listed.
NCT01671839 reports a single indexed study location in Louisiana, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01671839 about?
NCT01671839 is a clinical study titled "Study of the Cabochon System for Improvement in the Appearance of Cellulite". The purpose of this study is to evaluate the safety and effectiveness of the Cabochon System for the improvement in the appearance of cellulite.
What is the current status of trial NCT01671839?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2012-08. Estimated completion is 2015-12.
What conditions does trial NCT01671839 study?
This clinical trial studies the following conditions: Gynoid Lipodystrophy.
What interventions are being tested in trial NCT01671839?
The interventions under investigation include: Subcutaneous tissue release with the Cabochon System (DEVICE).
Who is sponsoring clinical trial NCT01671839?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01671839 being conducted?
This trial has 3 study locations across Louisiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01671839's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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