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CoolSculpting® Elite for Non-Invasive Fat Reduction

NCT04897867 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-10-05

Study results available
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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.

Conditions

  • Non-invasive Fat Reduction

Interventions

DEVICE

CoolSculpting® Elite System with CoolSculpting® Elite applicators

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • ALLERGAN INC. · Allergan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-06-15
Completion
2022-06-15
FDA Device
Yes

Countries

  • United States
  • France
  • Germany
  • Singapore
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04897867 on ClinicalTrials.gov