CompletedNCT02787850CCIUpdated Dec 3, 2021Results posted

CoolSculpting in the Abdomen Using Applicator With and Without CCI

An interventional study of CoolSculpting Treatment in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by Zeltiq Aesthetics · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Non-randomized
Ages: 22 Years to 65 Years
Sex: All

Study 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 the detailed description

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

Conditions studied

Body Fat Disorder

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Lipid Metabolism Disorders 180

In context

Lipid Metabolism Disorders

180 studies on the registry are indexed under Lipid Metabolism Disorders; 33 are open to participants now.

This study's enrollment of 20 is below the median of 51 across 136 interventional studies indexed under Lipid Metabolism Disorders.

Browse Lipid Metabolism Disorders studies →

Lead sponsor

Zeltiq Aesthetics is the lead sponsor of 39 studies on the registry; none are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 29 (100%) have results posted.

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

Who can participate

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

Eligibility criteria

Inclusion Criteria

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
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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
CoolSculpting Treatment Cohort A
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.
Device: CoolSculpting Treatment
Active comparator
CoolSculpting Treatment Cohort B
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.
Device: CoolSculpting Treatment

Interventions

DeviceCoolSculpting Treatment
The CoolSculpting device will be used to perform treatments.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Enrollment through 12 weeks post-treatment

Secondary outcomes

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.
Time frame: 12 weeks post-final treatment

Results

Posted Mar 1, 2021

Participant flow

Subjects seeking reduction of fat in the abdomen were recruited from the general population.

Participant flow — Overall Study
Milestone	CoolSculpting Treatment Cohort A	CoolSculpting Treatment Cohort B
Started	10	10
Completed	10	9
Not completed	0	1
Withdrew: Withdrawal by subject	0	1

Outcome measures

PrimaryPercentage 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.

Time frame:: 12 weeks post treatment
Reported as:: Count of units · photos

Percentage of Accurately Identified Pre-treatment Photos
photos	Overall Study Population-Both Cohorts	Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature	Abdomen Sites Treated With CCI for 45 Minutes	Abdomen Site Treated for 60 Minutes
Percentage of Accurately Identified Pre-treatment Photos	33	23	50	23

Statistical analysis

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
Abdomen Site Treated for 60 Minutes · Success proportion: 85.2 · 95% CI 66.3 to 95.8

PrimaryParticipants 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.

Time frame:: Enrollment through 12 weeks post-treatment
Reported as:: Number · UADEs

Participants With Unanticipated Adverse Device Effects (UADE)
UADEs	Cohort A	Cohort B
Participants With Unanticipated Adverse Device Effects (UADE)	0	0

SecondarySubject 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.

Time frame:: 12 weeks post-final treatment
Reported as:: Count of participants · Participants

Subject Satisfaction Questionnaire
Participants	Subgroup 1 Treatment Parameters	Subgroup 2 Treatment Parameters	Subgroup 3 Treatment Parameters
Very visible to visible fat reduction	8	16	8
Results expected or more than expected	7	14	7
Satisfied to very satisfied with procedure	9	17	7

Adverse events

Collected over Adverse event data were collected from enrollment through the 12-week final follow-up visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort A-Abdomen Side 1	0/10 (0%)	0/10 (0%)	1/10 (10%)
Cohort A-Abdomen Side 2	0/10 (0%)	0/10 (0%)	0/10 (0%)
Cohort B-Abdomen Side 1	0/10 (0%)	0/10 (0%)	0/10 (0%)
Cohort B- Abdomen Side 2	0/10 (0%)	0/10 (0%)	0/10 (0%)

Most frequent other events

Most frequent other events
Event	Cohort A-Abdomen Side 1	Cohort A-Abdomen Side 2	Cohort B-Abdomen Side 1	Cohort B- Abdomen Side 2
PainGeneral disorders	1/10	0/10	0/10	0/10

Baseline characteristics

Contralateral sides of each subject's abdomen treatment using protocol-defined.temperatures and time. Cohort A will receive treatment on half of the abdomen using the Crown Cooling Insert; the contralateral half will be treated with the Crown Cooling Insert. Cohort B will be treated with the Crown Cooling Insert on both halves of the abdomen.

Age, Categorical
Age, Categorical(Participants)	CoolSculpting Treatment Cohort A	CoolSculpting Treatment Cohort B	Total
<=18 years	0	0	0
Between 18 and 65 years	10	10	20
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	CoolSculpting Treatment Cohort A	CoolSculpting Treatment Cohort B	Total
Mean	44.4 (28 to 58)	36.2 (22 to 53)	40.3 (22 to 58)

Sex: Female, Male
Sex: Female, Male(Participants)	CoolSculpting Treatment Cohort A	CoolSculpting Treatment Cohort B	Total
Female	8	6	14
Male	2	4	6

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	CoolSculpting Treatment Cohort A	CoolSculpting Treatment Cohort B	Total
Hispanic or Latino	10	10	20
Not Hispanic or Latino	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	CoolSculpting Treatment Cohort A	CoolSculpting Treatment Cohort B	Total
United States	10	10	20

Study locations

1 site

Bowes Dermatology Group
Miami, Florida 33133, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02787850
Lead sponsor: Zeltiq Aesthetics
Responsible party: Sponsor
First posted: Jun 1, 2016
Start date: Apr 18, 2016
Primary completion: Aug 31, 2016
Completion: Aug 31, 2016
Results posted: Mar 1, 2021
Last update: Dec 3, 2021

Study contacts

Leyda Bowes, MD

principal investigator · Bowes Dermatology Group

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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