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NCT04897867 · ClinicalTrials.gov registry record · Phase 4
CoolSculpting® Elite for Non-Invasive Fat Reduction
A Phase 4 study of Non-invasive Fat Reduction, sponsored by Allergan.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 8
- Study locations
NCT04897867: Completed Phase 4 study of Non-invasive Fat Reduction, sponsored by Allergan.
NCT04897867 is a Phase 4 study of Non-invasive Fat Reduction that has completed, run by Allergan. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04897867, a Phase 4 study of Non-invasive Fat Reduction, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.
Primary Outcome
The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Conditions Studied
Interventions
- DEVICE CoolSculpting® Elite System with CoolSculpting® Elite applicators
Study Locations (8)
Other
- Centre Laser International de la Peau /ID# 239117 - Paris
- Bodenseeklinik /Id# 239155 - Lindau
- Halley Medical Aesthetics /ID# 239124 - Singapore
- Akademikliniken /ID# 239120 - Stockholm
California
- Laser & Skin Surgery Medical group, Inc /ID# 239112 - Sacramento
- Cosmetic Laser Dermatology /ID# 239110 - San Diego
- Cosmetic Laser Dermatology /ID# 239111 - San Diego
New York
- Laser & Skin Surgery Center of New York /ID# 239113 - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 4 |
What the finished NCT04897867 record still lists
NCT04897867 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Non-invasive Fat Reduction appearing as the primary indexed condition, and to 1 intervention - of which CoolSculpting® Elite System with CoolSculpting® Elite applicators is the first listed.
NCT04897867 lists 8 locations in 3 states (Other, California, New York).
Frequently Asked Questions
What is clinical trial NCT04897867 about?
NCT04897867 is a clinical study titled "CoolSculpting® Elite for Non-Invasive Fat Reduction". This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner...
What is the current status of trial NCT04897867?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2021-05-18. Estimated completion is 2022-06-15.
What conditions does trial NCT04897867 study?
This clinical trial studies the following conditions: Non-invasive Fat Reduction.
What interventions are being tested in trial NCT04897867?
The interventions under investigation include: CoolSculpting® Elite System with CoolSculpting® Elite applicators (DEVICE).
Who is sponsoring clinical trial NCT04897867?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04897867 being conducted?
This trial has 8 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04897867's enrollment target sits among peer trials
110 727th of 2000 higher than 1,264 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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