A Study to Assess Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this protocol is the continued collection of data specific to the submental, inner thigh and back/bra body areas with CoolSculpting Elite. The study aims to collect post-market safety data while allowing for the collection of standardized photos and satisfaction questionnaires after treatment with commercial treatment parameters.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CoolSculpting® Elite for Non-Invasive Fat Reduction

NCT04897867

Non-invasive Fat Reduction

COMPLETED PHASE4

Subcutaneous Fat Reduction in the Submental Area

NCT02298322

Body Fat Disorder

COMPLETED NA

CoolSculpting System

NCT04506307

Body Fat Disorder

COMPLETED NA

Non-Invasive Reduction of Fat in the Inner Thighs

NCT01517659

Body Fat Disorder

COMPLETED NA

Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature

NCT01600638

Body Fat Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Surgical Fat Reduction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A: Submental

Participants will receive applications of the CoolSculpting Elite System in the submental body area.

Group Type OTHER

CoolSculpting Elite System

Intervention Type DEVICE

CoolSculpting Elite Applicator

Cohort B: Inner Thigh

Participants will receive applications of the CoolSculpting Elite System in the inner thigh (bilateral) body area.

Group Type OTHER

CoolSculpting Elite System

Intervention Type DEVICE

CoolSculpting Elite Applicator

Cohort C: Back/Bra

Participants will receive applications of the CoolSculpting Elite System in the back/bra (bilateral) body area.

Group Type OTHER

CoolSculpting Elite System

Intervention Type DEVICE

CoolSculpting Elite Applicator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CoolSculpting Elite System

CoolSculpting Elite Applicator

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant has clearly visible fat on the submental, bilateral inner thigh or bilateral back/bra areas, which in the investigator's opinion, is appropriate for treatment with CoolSculpting Elite.
* Participant has not had weight change exceeding 5% of body weight in the preceding month.

Exclusion Criteria

* Participant has had a recent surgical procedure in the area of intended treatment within the previous 6 months.
* Participant has had previous surgical or invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Participant has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the previous 12 months.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes