Non-Surgical Fat ReductionPhase 4NCT07122583
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 study testing CoolSculpting Elite System in people with Non-Surgical Fat Reduction, run by AbbVie at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Surgical Fat Reduction
- What is being tested?
- CoolSculpting Elite System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 3 Jun 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Clinical Innovations
Vista, California, 92083
About this study
Official 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
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
- Being tested
- CoolSculpting Elite System
- Keywords
- Non-Surgical Fat Reduction, CoolSculpting Elite System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolSculpting Elite SystemDevice
CoolSculpting Elite Applicator
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Submental | Other | Participants will receive applications of the CoolSculpting Elite System in the submental body area. Receives: 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. Receives: 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. Receives: Device: CoolSculpting Elite System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Approximately 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start22 Jul 2025
- Primary completion3 Jun 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Surgical Fat ReductionStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122583
- Sponsor's protocol ID
- M25-970
- Other IDs
- ZA24-002
- Status last verified
- Jun 2026
- First submitted
- 8 Aug 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.