DualSculpting the Abdomen Using CoolSculpting

NCT02941146 | Completed Results FDA Device

• 1 other identifier: ZA16-004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• Proportion of Correctly Identified Photos by Blinded Reviewers

  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 will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be 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. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.

  Baseline to 12 weeks post-treatment

• Safety of the Zeltiq Device

  The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.

  12 week post-treatment

Secondary Outcomes (1)

• Subject Satisfaction

  12 weeks post-treatment

Study Arms (1)

Zeltiq Dual Sculpting Treatment Group

EXPERIMENTAL

All subjects treated with CoolSculpting System using the CoolAdvantage and CoolAdvantage Plus applicators simultaneously on the abdomen.

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.

Zeltiq Dual Sculpting Treatment Group

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects \>22 years of age and \< 65 years of age.
• Subject who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus applicator.
• No weight change exceeding 5% of body weight in the preceding month.
• Subject agrees to maintain his/her weight (i.e., within 5%) 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.

You may not qualify if:

• Subject has had a surgical procedure(s) in the area of intended treatmentSubject has had a surgical procedure(s) in the area of intended treatment.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
• Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria.
• Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
• Subject is pregnant or intending to become pregnant during the study period
• Subject is lactating or has been lactating in the past 6 months.
• Subject has a history of hernia in the areas to be treated.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Results Point of Contact

• Title: Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs
• Organization: Zeltiq Aesthetics

kerrie.jiang@allergan.com

(925) 621-7462

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: December 6, 2021
• Results First Posted: December 21, 2020

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)