Body Fat DisorderARMNCT02939105
CoolSculpting Treatment in the Upper Arms
A study testing The ZELTIQ CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in Canada.
Trial summary
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms. 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 CoolSculpting System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 2 Dec 2016to 3 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 has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 5% in the preceding month.
- Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) 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
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
- History of prior surgery in the arms.
- 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.
- History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
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- Currently taking or has taken diet pills or weight control supplements within the past month.
- Any dermatological conditions, such as scars, infection, 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.
About this study
Official title: DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.
Read the detailed description
Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.
- Conditions
- Body Fat Disorder
- Being tested
- The ZELTIQ CoolSculpting System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ZELTIQ CoolSculpting SystemDevice
The CoolSculpting device will be used to perform treatments.
| Study group | Role | What they receive |
|---|---|---|
| CoolSculpting Treatment in the Upper Arm | Experimental | Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures.
The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area. Receives: Device: The ZELTIQ CoolSculpting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Correctly 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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.
Measured: 12 weeks post-final treatment
Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms
The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.
Measured: Enrollment through12 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.
- First posted19 Oct 2016 (estimated)
- Study start2 Dec 2016
- Primary completion3 Mar 2017
- Study completion3 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Rivers, MD, Principal investigator, Pacific Dermaesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939105
- Sponsor's protocol ID
- ZA16-005
- Acronym
- ARM
- Status last verified
- May 2021
- First submitted
- 18 Oct 2016
- Last updated
- 9 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rivers JK, Ulmer M, Vestvik B, Santos S. A customized approach for arm fat reduction using cryolipolysis. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22811. Online ahead of print.
PubMed 29566270
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
- ClinicalTrials.gov ID
- NCT02939105
- Acronym / sponsor ID
- ARM / ZA16-005
- Conditions
- Body Fat Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Posted 9 Jun 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 the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.
Detailed description
Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoolSculpting Treatment in the Upper Arm | Experimental | Device: The ZELTIQ CoolSculpting SystemSubjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures. The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area. |
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 has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 5% in the preceding month.
- Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) 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 (13 listed)
- History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
- History of prior surgery in the arms.
- 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.
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 CoolSculpting SystemThe CoolSculpting device will be used to perform treatments. | Device | CoolSculpting Treatment in the Upper Arm |
Primary outcome
Proportion of Correctly Identified Pre-treatment Photos
Time frame: 12 weeks post-final 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 are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.
Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms
Time frame: Enrollment through12 weeks post-final treatment
The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29566270Rivers JK, Ulmer M, Vestvik B, Santos S. A customized approach for arm fat reduction using cryolipolysis. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22811. Online ahead of print.
- 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.
Jason Rivers, MD principal investigator
Pacific Dermaesthetics
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 CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in Canada.
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 13 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 9 Jun 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 Canada. 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 9 Jun 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?
Proportion of Correctly Identified Pre-treatment Photos (time frame: 12 weeks post-final 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 NCT02939105, which also lists 1 linked publication.
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 9 Jun 2021.