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

NCT07122583 | Active Not Recruiting Phase 4 FDA Device

• 2 other identifiers: M25-970ZA24-002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Surgical Fat Reduction

Keywords

Non-Surgical Fat Reduction; CoolSculpting Elite System

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Device and/or Procedure-Related Adverse Events (AEs)

  Frequency of device and procedure-related AEs including serious device-related adverse events (SADEs), will be analyzed per cohort.

  Up to Approximately 6 Months

Study Arms (3)

Cohort A: Submental

OTHER

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

Device: CoolSculpting Elite System

Cohort B: Inner Thigh

OTHER

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

Device: CoolSculpting Elite System

Cohort C: Back/Bra

OTHER

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

Device: CoolSculpting Elite System

Interventions

CoolSculpting Elite System DEVICE

CoolSculpting Elite Applicator

Cohort A: Submental; Cohort B: Inner Thigh; Cohort C: Back/Bra

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Pacific Clinical Innovations

Vista, California, 92083, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (1)