Body Fat DisorderDSANCT02941146

DualSculpting the Abdomen Using CoolSculpting

A study testing The ZELTIQ System 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 abdominal DualSculpting with CoolAdvantage applicators. 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?: The ZELTIQ System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Oct 2016to 29 Mar 2017
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 who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus 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.

Who cannot join

Subject has had a surgical procedure(s) in the area of intended treatmentSubject 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.

Show all 16Show fewer

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
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003

Other trials in United States

About this study

Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.

Read the detailed description

The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.

Conditions: Body Fat Disorder
Being tested: The ZELTIQ System

What participants receive

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

The ZELTIQ SystemDevice
The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.

Study groups in NCT02941146
Study group	Role	What they receive
Zeltiq Dual Sculpting Treatment Group	Experimental	All subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen. Receives: Device: The ZELTIQ System

What is being measured

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

Proportion of Correctly Identified Photos by Blinded Reviewers
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. 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. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.
Measured: Baseline to 12 weeks post-treatment
Safety of the Zeltiq Device
The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.
Measured: 12 week post-treatment

Secondary outcomes (1)

Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses.
Measured: 12 weeks post-treatment

Timeline

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

Oct 201629 Mar 2017

First posted21 Oct 2016 (estimated)
Study startOct 2016
Primary completion29 Mar 2017
Study completion29 Mar 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02941146
Sponsor's protocol ID: ZA16-004
Acronym: DSA
Status last verified: Oct 2016
First submitted: 19 Oct 2016
Last updated: 6 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DualSculpting the Abdomen Using CoolSculpting
ClinicalTrials.gov ID: NCT02941146
Acronym / sponsor ID: DSA / ZA16-004
Conditions: Body Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: Oct 2016 (actual)
Primary completion: 29 Mar 2017 (actual)
Study completion: 29 Mar 2017 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Posted 21 Dec 2020

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 abdominal DualSculpting with CoolAdvantage applicators.

Detailed description

The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Zeltiq Dual Sculpting Treatment Group	Experimental	Device: The ZELTIQ SystemAll subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen.

Who may qualify

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

Key inclusion criteria (5 listed)

Male or female subjects >22 years of age and < 65 years of age.
Subject who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus 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.

Key exclusion criteria (16 listed)

Subject has had a surgical procedure(s) in the area of intended treatmentSubject 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.

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
The ZELTIQ SystemThe CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.	Device	Zeltiq Dual Sculpting Treatment Group

Primary outcome

Proportion of Correctly Identified Photos by Blinded Reviewers
Time frame: Baseline to 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. 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. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.
Safety of the Zeltiq Device
Time frame: 12 week post-treatment
The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.

1 secondary outcome

Subject Satisfaction
Time frame: 12 weeks post-treatment

Results and safety

Results posted to the registry on 21 Dec 2020, 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 of the Abdomen	15	15

Primary outcome: Proportion of Correctly Identified Photos by Blinded Reviewers

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

Measure	CoolSculpting of the Abdomen With Dual Applicators n = 14
Value	28

CoolSculpting of the Abdomen With Dual Applicators: sucess proportion: 64.3 (95% CI 35.1 to 87.2)

Population analysed: Fourteen of 15 treated subjects were included in the per-protocol analysis. One subject was excluded from analysis due to a protocol-defined weight maintenance requirement. Pre-treatment and post-treatment photos were evaluated by 3 independent physician reviewers.

Primary outcome: Safety of the Zeltiq Device

Time frame: 12 week post-treatment. Number. Unit: device-or procedure-related AEs

Measure	CoolSculpting of the Abdomen With Dual Applicators n = 15
Value	0

Population analysed: The "as-treated" population included all subjects who were treated with CoolSculpting.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was solicited continuously throughout the study. The final follow-up visit occurred 12 weeks post-treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CoolSculpting of the Abdomen With Dual Applicators	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing The ZELTIQ System 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 5 inclusion and 16 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 6 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 21 Dec 2020). 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?

Proportion of Correctly Identified Photos by Blinded Reviewers (time frame: Baseline to 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 NCT02941146.

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 6 Dec 2021.