Body Fat DisorderCCINCT02787850

CoolSculpting in the Abdomen Using Applicator With and Without CCI

A study testing CoolSculpting Treatment in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert. Read more about this study

Who is it for?: Ages 22 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Body Fat Disorder
What is being tested?: CoolSculpting Treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2016to 31 Aug 2016
Phase: Interventional
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female subjects >22 years of age and < 65 years of age.
Subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment.
Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
No weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
Subject has read and signed the study written informed consent form. Exclusion Criteria

Show all 23Show fewer

Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Subject is taking or has taken diet pills or supplements within the past month.
Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
Subject is lactating or has been lactating in the past 6 months.
Subject has a history of hernia in the areas to be treated.
Subject is unable or unwilling to comply with the study requirements.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Subject is prone to severe claustrophobia (during MRI scans).
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bowes Dermatology Group
Miami, Florida, 33133

Other trials in United States

About this study

Official title: CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Read the detailed description

Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Conditions: Body Fat Disorder
Being tested: CoolSculpting Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoolSculpting TreatmentDevice
The CoolSculpting device will be used to perform treatments.

Study groups in NCT02787850
Study group	Role	What they receive
CoolSculpting Treatment Cohort A	Experimental	Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes using the CoolMax applicator without the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with the Crown Cooling Insert at a second protocol-defined temperature for 45 minutes. Each half of the abdominal area will be treated once, for a total of two treatments per subject. Receives: Device: CoolSculpting Treatment
CoolSculpting Treatment Cohort B	Active comparator	Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes using the CoolMax applicator with the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with a second protocol-defined temperature for 60 minutes with the Crown Cooling Insert. Each half of the abdominal area will be treated once, for a total of two treatments per subject. Receives: Device: CoolSculpting Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Accurately Identified Pre-treatment Photos
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.
Measured: 12 weeks post treatment
Participants With Unanticipated Adverse Device Effects (UADE)
The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.
Measured: Enrollment through 12 weeks post-treatment

Secondary outcomes (1)

Subject Satisfaction Questionnaire
Subject satisfaction with the treatment experience data will also be collected via a written questionnaire at the 12-week follow up visits. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very satisfied; 2) somewhat satisfied; 3) neither satisfied nor unsatisfied; 4) somewhat unsatisfied; 5) very unsatisfied.
Measured: 12 weeks post-final treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201631 Aug 2016

First posted1 Jun 2016 (estimated)
Study start18 Apr 2016
Primary completion31 Aug 2016
Study completion31 Aug 2016

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 Body Fat DisorderStudies 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 N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02787850
Sponsor's protocol ID: ZA16-002
Acronym: CCI
Status last verified: Feb 2021
First submitted: 26 May 2016
Last updated: 3 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Body Fat Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert
ClinicalTrials.gov ID: NCT02787850
Acronym / sponsor ID: CCI / ZA16-002
Conditions: Body Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 18 Apr 2016 (actual)
Primary completion: 31 Aug 2016 (actual)
Study completion: 31 Aug 2016 (actual)
First posted: 1 Jun 2016 (estimated)
Results: Posted 1 Mar 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Detailed description

Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CoolSculpting Treatment Cohort A	Experimental	Device: CoolSculpting TreatmentCohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes using the CoolMax applicator without the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with the Crown Cooling Insert at a second protocol-defined temperature for 45 minutes. Each half of the abdominal area will be treated once, for a total of two treatments per subject.
CoolSculpting Treatment Cohort B	Active comparator	Device: CoolSculpting TreatmentCohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes using the CoolMax applicator with the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with a second protocol-defined temperature for 60 minutes with the Crown Cooling Insert. Each half of the abdominal area will be treated once, for a total of two treatments per subject.

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Male or female subjects >22 years of age and < 65 years of age.
Subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment.
Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
No weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.

Key exclusion criteria (0 listed)

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 TreatmentThe CoolSculpting device will be used to perform treatments.	Device	CoolSculpting Treatment Cohort A, CoolSculpting Treatment Cohort B

Primary outcome

Percentage of Accurately Identified Pre-treatment Photos
Time frame: 12 weeks post treatment
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.
Participants With Unanticipated Adverse Device Effects (UADE)
Time frame: Enrollment through 12 weeks post-treatment
The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.

1 secondary outcome

Subject Satisfaction Questionnaire
Time frame: 12 weeks post-final treatment

Results and safety

Results posted to the registry on 1 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CoolSculpting Treatment Cohort A	10	10
CoolSculpting Treatment Cohort B	10	9

Primary outcome: Percentage of Accurately Identified Pre-treatment Photos

Time frame: 12 weeks post treatment. Count of units. Unit: photos

Measure	Overall Study Population-Both Cohorts n = 19	Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature n = 10	Abdomen Sites Treated With CCI for 45 Minutes n = 19	Abdomen Site Treated for 60 Minutes n = 9
Value	33	23	50	23

Overall Study Population-Both Cohorts: sucess proportion: 86.8 (95% CI 71.9 to 95.6)
Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature: success proportion: 76.7 (95% CI 57.7 to 90.1)
Abdomen Sites Treated With CCI for 45 Minutes: success proportion: 87.7 (95% CI 76.3 to 94.9)

Population analysed: The analysis population consisted of 19 subjects with evaluable images. Six images from each subject's abdomen were reviewed by the independent reviewers.

Primary outcome: Participants With Unanticipated Adverse Device Effects (UADE)

Time frame: Enrollment through 12 weeks post-treatment. Number. Unit: UADEs

Measure	Cohort A n = 10	Cohort B n = 9
Value	0	0

Population analysed: Subjects who received CoolSculpting treatment for reduction of subcutaneous fat in the abdomen were included in the analysis population. Of the 20 subjects enrolled and treated, one subject withdrew prior to study completion.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from enrollment through the 12-week final follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A-Abdomen Side 1	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Cohort A-Abdomen Side 2	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Cohort B-Abdomen Side 1	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Cohort B- Abdomen Side 2	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Leyda Bowes, MD principal investigator

Bowes Dermatology Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CoolSculpting Treatment in people with Body Fat Disorder, run by Zeltiq Aesthetics 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 23 inclusion and 0 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 3 Dec 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2021). 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 Accurately Identified Pre-treatment Photos (time frame: 12 weeks post treatment). 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?

On the ClinicalTrials.gov record for NCT02787850.

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 3 Dec 2021; AzTrials last refreshed its copy on 3 Nov 2026.