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CompletedNCT07122583Updated Jul 2, 2026

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

A Phase 4 interventional study of CoolSculpting Elite System in Non-Surgical Fat Reduction, sponsored by AbbVie. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by AbbVie · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Non-randomized
Ages
22 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Surgical Fat Reduction

Keywords

  • Non-Surgical Fat Reduction
  • CoolSculpting Elite System
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Other
    Cohort A: Submental

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

    Device: CoolSculpting Elite System

  • Other
    Cohort B: Inner Thigh

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

    Device: CoolSculpting Elite System

  • Other
    Cohort C: Back/Bra

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

    Device: CoolSculpting Elite System

Interventions

  • DeviceCoolSculpting Elite System

    CoolSculpting Elite Applicator

06

What researchers measure

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.

    Time frame: Up to Approximately 6 Months

07

Study locations

1 site
  • Pacific Clinical Innovations
    Vista, California 92083, United States
08

References and documents

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07122583
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Aug 14, 2025
Start date
Jul 22, 2025
Primary completion
Jun 3, 2026
Completion
Jun 3, 2026
Last update
Jul 2, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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