Body Fat DisorderNCT01859091
Pilot Study on the Submental Area
A study testing The Zeltiq System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat. Read more about this study
- Who is it for?
- Ages 18 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
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Oct 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 18 years of age and < 65 years of age.
- Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 10 pounds in the preceding month.
- Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has signed a written informed consent form.
Who cannot join
- Skin laxity in the neck or chin area for which reduction in submental fat may.
- Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
- Enlargement on the anterior neck that may prevent the proper placement of the applicator.
- Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
- Botulinum toxin injections within the neck or chin area.
- History of a fat reduction procedure in the area of intended treatment.
Show all 20Show fewer
- History of prior surgery in the area of intended treatment.
- Current dental infection.
- Known history of cryoglobulinemia, cold urticaria, 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.
- Impaired skin sensation or thermal sensitivity in the intended treatment area.
- Open or infected wounds in the intended treatment area.
- 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, defibrillator, or drug delivery system.
- Pregnant or intending to become pregnant in the next 5 months.
- Lactating or has been lactating in the past 6 months.
- Unable or unwilling to comply with the study requirements.
- 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
Innovation Research Center
Pleasanton, California, 94588
About this study
Official title: Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.
- Conditions
- Body Fat Disorder
- Being tested
- The Zeltiq System
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Zeltiq SystemDevice
Also called Cryolipolysis, Lipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| Fat Reduction | 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 Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
Measured: 8-weeks post treatment
Secondary outcomes (2)
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 8-week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.
Measured: Baseline, 8-weeks post treatment
Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)
Photographs of the treatment areas taken at baseline and 8-weeks after final treatment were assessed for visible changes in contour in the treated areas. Pre- and post-treatment photograph pairs were randomized and reviewed by a blinded reviewer panel of 4 reviewers.
Measured: 8-weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionOct 2014
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859091
- Sponsor's protocol ID
- ZA13-004
- Status last verified
- Aug 2025
- First submitted
- 16 May 2013
- Last updated
- 15 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
- ClinicalTrials.gov ID
- NCT01859091
- Acronym / sponsor ID
- ZA13-004
- Conditions
- Body Fat Disorder
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Posted 15 Aug 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 feasibility of cryolipolysis for non-invasive reduction of submental fat.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fat Reduction | Experimental | Device: The Zeltiq System |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects > 18 years of age and < 65 years of age.
- Presence of submental fat, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 10 pounds in the preceding month.
- Agreement to maintain his/her weight (i.e., within 10 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has signed a written informed consent form.
Key exclusion criteria (20 listed)
- Skin laxity in the neck or chin area for which reduction in submental fat may.
- Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
- Enlargement on the anterior neck that may prevent the proper placement of the applicator.
- Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area.
- Botulinum toxin injections within the neck or chin area.
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 SystemAlso: Cryolipolysis, LipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | Fat Reduction |
Primary outcome
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
Time frame: 8-weeks post treatment
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
2 secondary outcomes
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Time frame: Baseline, 8-weeks post treatment
Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)
Time frame: 8-weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 20 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 15 Aug 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 15 Aug 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 Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) (time frame: 8-weeks post treatment). 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 15 Aug 2025.