- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03873779
CoolSculpting and RF for the Submental (CRT)
August 14, 2020 updated by: Zeltiq Aesthetics
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Pleasanton, California, United States, 94588
- Innovation Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the submental/submandibular area.
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The CoolSculpting machine will be used to perform the treatments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of unanticipated adverse device effects (UADE). It is expected there will be zero UADE's.
Time Frame: 12-weeks post final treatment
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The primary safety endpoint is measurement of unanticipated adverse device effects.
All adverse events reported during and following the treatment will be included in the safety analysis.
The frequency and proportion of subjects reporting each type of adverse event will be tabulated by relationship with the treatment and severity of the event.
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12-weeks post final treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of overall treatment outcome in submental and submandibular area using Subject-graded GAIS (SGAIS)
Time Frame: 12-weeks post final treatment
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Overall improvement in the targeted area will be assessed by the subject using the GAIS at 12-weeks post-final treatment.
The assessment will consist of writing the outcome as: Very much improved; much improved; improved; no change; worse; much worse; very much worse.
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12-weeks post final treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2018
Primary Completion (Anticipated)
August 1, 2020
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
December 18, 2018
First Submitted That Met QC Criteria
March 11, 2019
First Posted (Actual)
March 13, 2019
Study Record Updates
Last Update Posted (Actual)
August 18, 2020
Last Update Submitted That Met QC Criteria
August 14, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA18-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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