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OpenTrials
Completed

NCT Number: NCT07122583

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

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.

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Key information

Conditions

Non-Surgical Fat Reduction

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pacific Clinical Innovations

Vista, California, 92083, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CoolSculpting Elite System

Device

CoolSculpting Elite Applicator

Primary outcomes

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

    Time frame: Up to Approximately 6 Months

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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Study to Collect Post-Market Data on Non-Invasive Subcutaneous Fat Reduction in the Submental, Inner Thigh and Back/Bra Areas With the CoolSculpting Elite System

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.