Non-invasive Fat ReductionPhase 4NCT04897867
CoolSculpting® Elite for Non-Invasive Fat Reduction
A Phase 4 study testing CoolSculpting® Elite System with CoolSculpting® Elite applicators in people with Non-invasive Fat Reduction, run by Allergan at 8 sites in 5 countries.
Trial summary
This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer… Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Non-invasive Fat Reduction
- What is being tested?
- CoolSculpting® Elite System with CoolSculpting® Elite applicators
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 18 May 2021to 15 Jun 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
- Participant has clearly visible and palpable fat in the abdomen and flanks, and participant may also be assessed for visible and palpable fat in one or more of the following body areas: left and right lower aspects of the upper arms, left and right inner thigh, left and right outer thigh, or submental area, which in the investigator's opinion is appropriate for and may benefit from treatment.
- Participant has a BMI of ≥ 18.5 and < 30. BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
- Participant agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
- Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Who cannot join
- Participant has a history of an invasive fat reduction procedure (eg, liposuction, surgery, lipolytic agents, etc) within or adjacent to the area being considered for treatment.
- Participant has implants (eg, breast implants) in or immediately adjacent to the area of intended treatment.
- Participant has a history of prior surgery or scar tissue related to the area being considered for treatment.
- Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
- Participant has a known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud's disease, or chilblains (pernio).
- Participant with a clinically significant bleeding disorder, or concomitant use of blood thinners, or is taking any medication that, in the investigator's opinion, may significantly increase the participant's risk of bruising or bleeding.
Show all 23Show fewer
- Participant has a history of carpal tunnel syndrome, compartment syndrome, or deep vein thrombosis in the upper or lower extremities (only applicable for participants receiving treatment to the upper arms or thighs).
- Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months.
- Participant has any skin conditions, such as moderate to excessive skin laxity, open wound, or scars, and active infection, eczema, dermatitis or rashes in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks are not an exclusion).
- Participant has an active implanted device such as a pacemaker, defibrillator, drug delivery system, or any other metal-containing implant, within or adjacent to the area being considered for treatment.
- Participant (WOCBP- woman of childbearing potential) is pregnant or intending to become pregnant in the next 3 to 6 months and does not agree to use reliable contraception during the study.
- Participant is lactating or has been lactating in the past 6 months.
- Participant is unable or unwilling to comply with the study requirements.
- Participant is currently enrolled in a clinical study of any unapproved investigational device, investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Participant has any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the participant's response or the integrity of the data or would pose an unacceptable risk to the participant.
- Participant has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
- Participant needs to administer, or has a known history of subcutaneous injections, into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
- Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
- Participant has impaired peripheral circulation in the area to be treated.
- Participant has neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
- Participant has impaired skin sensation in or immediately adjacent to the treatment area(s).
- Participant has a history of hernia in or immediately adjacent to the treatment area(s).
- Participant diagnosed with a systemic fibrosing disease or fibrosis in the area intended or adjacent to the area to be treated.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States4 sites
Laser & Skin Surgery Center of New York /ID# 239113
New York, New York, 10016-4974
Laser & Skin Surgery Medical group, Inc /ID# 239112
Sacramento, California, 95816-5520
Cosmetic Laser Dermatology /ID# 239110
San Diego, California, 92121-2119
Cosmetic Laser Dermatology /ID# 239111
San Diego, California, 92121-2119
About this study
Official title: CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area
This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.
- Conditions
- Non-invasive Fat Reduction
- Being tested
- CoolSculpting® Elite System with CoolSculpting® Elite applicators
- Keywords
- Fat Reduction Non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoolSculpting® Elite System with CoolSculpting® Elite applicatorsDevice
A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
| Study group | Role | What they receive |
|---|---|---|
| CoolSculpting® Elite System | Experimental | Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. Receives: Device: CoolSculpting® Elite System with CoolSculpting® Elite applicators |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection
The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Measured: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.
Measured: First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions)
Secondary outcomes (3)
Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With "Satisfied" or "Very Satisfied" on CSQ-Overall Item 1
The CSQ-Overall is a 1-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® Elite treatment when midsection and one or more additional body area were selected for treatment. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure when considering the treated areas using a 5-item scale ranging from Very satisfied to Very dissatisfied.
Measured: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
The CSQ- Upper Arms, CSQ-Inner Thighs, CSQ-Outer Thighs, CSQ-Fat Under Chin are 1-item Patient-reported Outcome (PRO) instruments that measure participant's satisfaction with CoolSculpting® Elite treatment for the optional additional individual body area(s) treated. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure for the optional additional individual body area(s) treated on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Measured: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Success was defined as at least 70% correct identification of the pre-treatment images.
Measured: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start18 May 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-invasive Fat ReductionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ALLERGAN INC., Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897867
- Sponsor's protocol ID
- MED-MA-PLS-0647
- Status last verified
- Oct 2023
- First submitted
- 14 May 2021
- Last updated
- 5 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area
- ClinicalTrials.gov ID
- NCT04897867
- Acronym / sponsor ID
- MED-MA-PLS-0647
- Conditions
- Non-invasive Fat Reduction
- Keywords
- Fat Reduction Non-invasive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 5 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoolSculpting® Elite System | Experimental | Device: CoolSculpting® Elite System with CoolSculpting® Elite applicatorsParticipants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
- Participant has clearly visible and palpable fat in the abdomen and flanks, and participant may also be assessed for visible and palpable fat in one or more of the following body areas: left and right lower aspects of the upper arms, left and right inner thigh, left and right outer thigh, or submental area, which in the investigator's opinion is appropriate for and may benefit from treatment.
- Participant has a BMI of ≥ 18.5 and < 30. BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
- Participant agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
- Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Key exclusion criteria (23 listed)
- Participant has a history of an invasive fat reduction procedure (eg, liposuction, surgery, lipolytic agents, etc) within or adjacent to the area being considered for treatment.
- Participant has implants (eg, breast implants) in or immediately adjacent to the area of intended treatment.
- Participant has a history of prior surgery or scar tissue related to the area being considered for treatment.
- Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
- Participant has a known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud's disease, or chilblains (pernio).
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 System with CoolSculpting® Elite applicatorsA treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. | Device | CoolSculpting® Elite System |
Primary outcome
Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied.
Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs
Time frame: First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions)
An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made.
3 secondary outcomes
Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With "Satisfied" or "Very Satisfied" on CSQ-Overall Item 1
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)
Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers
Time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
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.
ALLERGAN INC. study director
Allergan
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CoolSculpting® Elite System with CoolSculpting® Elite applicators in people with Non-invasive Fat Reduction, run by Allergan at 8 sites in 5 countries.
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 5 inclusion and 23 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 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France, Germany, Singapore, Sweden. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection (time frame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions)). The study lists 2 primary outcomes in all. 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 5 Oct 2023; AzTrials last refreshed its copy on 31 Oct 2026.