CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 110 enrolled
Drug / intervention
CoolSculpting® Elite System with CoolSculpting® Elite applicatorsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04897867
NCT04897867Phase 4Completed

CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area

Allergan·interventional·Posted May 24, 2021·Updated Oct 5, 2023

In Brief

A Phase 4 clinical trial evaluating CoolSculpting® Elite System with CoolSculpting® Elite applicators for Non-invasive Fat Reduction. Completed, enrolled 110 participants across 8 sites in 5 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Singapore, Sweden, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMay 24, 2021
Enrollment StartMay 18, 2021
Primary CompletionJun 15, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.1 years ago

Interventions

CoolSculpting® Elite System with CoolSculpting® Elite applicatorsdevice

A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.