Completed

EFCFeasibility Study of CoolSculpting Effects on Cellulite Appearance

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

The ZELTIQ System

Device
Who is being recruted

From 22 to 65 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: November 2020
See protocol details

Summary

Principal SponsorZeltiq Aesthetics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 13, 2020

Actual date on which the first participant was enrolled.

Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.

Official TitleFeasibility Study of CoolSculpting Effects on Cellulite Appearance
NCT04876118
Principal SponsorZeltiq Aesthetics
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

97 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 22 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Female subjects > 22 years of age and < 65 years of age.
Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment.
Subject has not had weight change exceeding 5% in the preceding month.
Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
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19 exclusion criteria prevent from participating
Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months.
Presence of significant suntan in the thighs.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The treatments are designed to see if the appearance of cellulite can be reduced on the outer thigh.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Investigate MD

Scottsdale, United StatesOpen Investigate MD in Google Maps
Suspended

Rebecca Fitzgerald, MD Dermatology

Los Angeles, United States
Suspended

Sasaki Advanced Aesthetics Medical Center

Pasadena, United States
Suspended

Innovation Research Center

Pleasanton, United States
Completed6 Study Centers