Body Fat DisorderCRTNCT03873779

CoolSculpting and RF for the Submental

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

The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area. 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: 8 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2018to 18 Jun 2019
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.
Treatment area skin fold thickness > 1cm (measured by caliper).
Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
No weight change exceeding 5% of body weight in the preceding month.
Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
Subject has signed a written informed consent form

Who cannot join

Body Mass Index ≥ 46.2 as determined at screening.
Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
Prominent platysmal bands at rest which may interfere with assessment of treatment area.
Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
Treatment with dermal fillers, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months.

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Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the treatment area in the past 6 months.
History of facial nerve paresis or paralysis (such as Bell's palsy).
History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
History of prior neck surgery, or prior surgery in the area of intended treatment.
Current infection in and adjacent to treatment area.
Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Currently taking or has taken diet pills or weight control supplements within the past month.
Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
Active implanted device such as a pacemaker, automatic implantable cardioverter/defibrillator (AICD), drug delivery system, or any other implantable electrical device.
Pregnant or intending to become pregnant in the next 6 months.
Lactating or has been lactating in the past 6 months.
Unable or unwilling to comply with the study requirements including remaining clean shaven for all study visits.
Currently enrolled in a clinical study of an 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

Innovation Research Center
Pleasanton, California, 94588

Other trials in United States

About this study

Official title: A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring

The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.

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
Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.

Study groups in NCT03873779
Study group	Role	What they receive
Cryolipolysis Followed by Radiofrequency Treatment	Experimental	Not described Receives: Device: The ZELTIQ System

What is being measured

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

Number of Participants With Unanticipated Adverse Device Effects (UADEs)
UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.
Measured: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").
Measured: Baseline, 12 weeks post radiofrequency treatment

Secondary outcomes (4)

Percent Change From Baseline in Fat Layer Thickness
Fat layer thickness was measured using a caliper at the center of the treatment area.
Measured: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)
Participants rated improvement in their treatment areas based on the SGAIS. The SGAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who reported as improved ("Very Much Improved," "Much Improved", and "Improved").
Measured: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score
Participants assessed their own satisfaction with their face and chin using the SSRS. The SSRS is a participants self-rating scale, scored on a 7-point scale with 0=extremely dissatisfied, 1=dissatisfied, 2=slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=slightly satisfied, 5=satisfied, and 6=extremely satisfied, with 6 representing higher participant satisfaction. Reported here is the number of participants with a score of 4 or higher, indicating satisfaction.
Measured: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Positive Response on Subject Satisfaction Questionnaire
Participants reported their satisfaction with aspects of treatment on a written questionnaire which included a 5-point Likert scale ranging from -2 to 2, with -2 representing more negative response and 2 representing more positive response. Reported here are the numbers of participants with responses of 1 or 2, indicating a positive response, to the following categories: Comfort of Treatment Procedure, How Visible is Fat Reduction, Overall Effect from the Procedure, Overall Satisfaction with Treatment from the Procedure to the Result, Made Me Look More Youthful, Made My Chin Look More Toned, Feel Less Self-Conscious About Chin Fat, Overall Appearance Has Improved.
Measured: Baseline, 12 Weeks Post Radiofrequency Treatment

Timeline

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

18 Dec 201818 Jun 2019

First posted13 Mar 2019
Study start18 Dec 2018
Primary completion18 Jun 2019
Study completion18 Jun 2019

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: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03873779
Sponsor's protocol ID: ZA18-002
Acronym: CRT
Status last verified: Feb 2025
First submitted: 18 Dec 2018
Last updated: 10 Mar 2025
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 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring
ClinicalTrials.gov ID: NCT03873779
Acronym / sponsor ID: CRT / ZA18-002
Conditions: Body Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 18 Dec 2018 (actual)
Primary completion: 18 Jun 2019 (actual)
Study completion: 18 Jun 2019 (actual)
First posted: 13 Mar 2019 (actual)
Results: Posted 10 Mar 2025

Clinical summary

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

The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.

Study design

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

Arm	Type	Receives
Cryolipolysis Followed by Radiofrequency Treatment	Experimental	Device: The ZELTIQ System

Who may qualify

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

Key inclusion criteria (6 listed)

Male or female subjects ≥22 years of age and ≤65 years of age.
Treatment area skin fold thickness > 1cm (measured by caliper).
Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
No weight change exceeding 5% of body weight in the preceding month.
Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.

Key exclusion criteria (22 listed)

Body Mass Index ≥ 46.2 as determined at screening.
Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
Prominent platysmal bands at rest which may interfere with assessment of treatment area.
Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.

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 SystemParticipants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.	Device	Cryolipolysis Followed by Radiofrequency Treatment

Primary outcome

Number of Participants With Unanticipated Adverse Device Effects (UADEs)
Time frame: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)
UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Time frame: Baseline, 12 weeks post radiofrequency treatment
Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").

4 secondary outcomes

Percent Change From Baseline in Fat Layer Thickness
Time frame: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)
Time frame: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score
Time frame: Baseline, 12 weeks post radiofrequency treatment
Number of Participants With Positive Response on Subject Satisfaction Questionnaire
Time frame: Baseline, 12 Weeks Post Radiofrequency Treatment

Results and safety

Results posted to the registry on 10 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cryolipolysis Followed by Radiofrequency Treatment	8	7

Primary outcome: Number of Participants With Unanticipated Adverse Device Effects (UADEs)

Time frame: From date of first treatment to 12 weeks after final treatment (up to 24 weeks). Count of participants. Unit: Participants

Measure	Cryolipolysis Followed by Radiofrequency Treatment n = 8
Value	0

Population analysed: The Safety Population consisted of all participants who received at least one study treatment.

Primary outcome: Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)

Time frame: Baseline, 12 weeks post radiofrequency treatment. Count of participants. Unit: Participants

Measure	Cryolipolysis Followed by Radiofrequency Treatment n = 6
Value	2

Population analysed: The Per-protocol population (PP) consisted of all participants who received both CoolSculpting and radiofrequency treatment, and had a weight change of no more than 5 percent at the time of the 12-week post final treatment visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of first treatment to 12 weeks after final treatment (up to 24 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cryolipolysis Followed by Radiofrequency Treatment	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Body Fat Disorder

Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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Mechanisms of Weight Loss: Tirzepatide vs Semaglutide
Obesity (Disorder)
Not yet recruiting
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Obesity & Overweight, Obesity Type I and II
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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 6 inclusion and 22 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 10 Mar 2025. 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 10 Mar 2025). 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?

Number of Participants With Unanticipated Adverse Device Effects (UADEs) (time frame: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)). 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 NCT03873779.

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 10 Mar 2025.