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
- Are there results?
- None posted in the registry
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07122583
- Acronym / sponsor ID
- M25-970
- Conditions
- Non-Surgical Fat Reduction
- Keywords
- Non-Surgical Fat Reduction, CoolSculpting Elite System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 3 Jun 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Submental | Other | Device: CoolSculpting Elite SystemParticipants will receive applications of the CoolSculpting Elite System in the submental body area. |
| Cohort B: Inner Thigh | Other | Device: CoolSculpting Elite SystemParticipants will receive applications of the CoolSculpting Elite System in the inner thigh (bilateral) body area. |
| Cohort C: Back/Bra | Other | Device: CoolSculpting Elite SystemParticipants will receive applications of the CoolSculpting Elite System in the back/bra (bilateral) body area. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoolSculpting Elite SystemCoolSculpting Elite Applicator | Device | Cohort A: Submental, Cohort B: Inner Thigh, Cohort C: Back/Bra |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CoolSculpting Elite System in people with Non-Surgical Fat Reduction, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Device and/or Procedure-Related Adverse Events (AEs) (time frame: Up to Approximately 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.