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CoolSculpting and RF for the Submental (CRT)

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ClinicalTrials.gov Identifier: NCT03873779
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Brief 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.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The ZELTIQ System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Feasibility Study to Explore the Safety and Efficacy of Cryolipolysis Followed by Radiofrequency Treatment for Submental and Submandibular Contouring
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the submental/submandibular area.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.




Primary Outcome Measures :
  1. Incidence of unanticipated adverse device effects (UADE). It is expected there will be zero UADE's. [ Time Frame: 12-weeks post final treatment ]
    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.


Secondary Outcome Measures :
  1. Assessment of overall treatment outcome in submental and submandibular area using Subject-graded GAIS (SGAIS) [ Time Frame: 12-weeks post final treatment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873779


Contacts
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Contact: Tonia N Madere 925-474-2537 tonia.madere@allergan.com

Locations
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United States, California
Innovation Research Center Recruiting
Pleasanton, California, United States, 94588
Contact: Lan La    925-474-2501    clinicalstudies@pleasantonirc.com   
Principal Investigator: Eric Bachelor, MD         
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
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Study Director: Kerrie Jiang, NP Zeltiq Aesthetics

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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT03873779     History of Changes
Other Study ID Numbers: ZA18-002
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases