CoolSculpting System

NCT04506307 | Completed Results FDA Device

• 1 other identifier: ZA20-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (1)

• Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel

  Photographs of the treatment areas (torso) taken at baseline and 12-weeks after final treatment were assessed by blinded independent reviewers to determine if the CoolSculpting treatment had the effect of improvement in the reduction of fat. The reviewers were presented with 2 series of photographs the baseline and the post final treatment series, and asked to select the series representing the baseline photographs. The order in which the photographs were presented was randomized by participant. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. Success was defined as at least 70% correct identification of the baseline images.

  Week 12 post final treatment (18 weeks after first treatment)

Secondary Outcomes (1)

• Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)

  From first treatment up to Week 12 post final treatment (18 weeks after first treatment)

Study Arms (1)

Fat Reduction

EXPERIMENTAL

The treatments are designed to see if the fat can be reduced in the torso area with a new applicator design.

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

The CoolSculpting machine will be used to perform the treatments.

Fat Reduction

Eligibility Criteria

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

You may qualify if:

• Subject (healthy volunteer) has read and signed the study written informed consent form.
• Male or female ≥ 22 years and ≤65 years of age.
• Subject has clearly visible fat in one or more areas on the torso (abdomen, flank, back fat, bra fat), which in the investigator's opinion, may benefit from the treatment.
• Subject has not had 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 study.
• Subject has a BMI ≤ 30 as determined at screening.
• Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

You may not qualify if:

• Subject has had a recent surgical procedure 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, paroxysmal cold hemoglobinuria, or cold agglutinin disease.
• Subject has a known sensitivity to cold, such as cold urticaria, Raynaud's disease, chilblains (pernio), 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
• Subject has a history of hernia in the area(s) to be treated.
• Subject is pregnant or intending to become pregnant during the study period (in the next 8 months).
• Subject is lactating or has been lactating in the past 6 months.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled in a clinical study of any 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 (4)

Marina Plastic Surgery

Marina del Rey, California, 90292, United States

Location

Leyda E Bowes MD

Pleasanton, California, 94588, United States

Location

Moradi MD Cosmetic Surgery

Vista, California, 92083, United States

Location

Riverchase Dermatology

Miami, Florida, 33133, United States

Location

Results Point of Contact

• Title: Sally Hallas, RN, Director Clinical Development - Body Contouring
• Organization: Zeltiq Aesthetics

sally.hallas@abbvie.com

209-294-5571

Study Officials

• Study Director

  Zeltiq Aesthetics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: August 6, 2020
• First Posted: August 10, 2020
• Study Start: March 13, 2020
• Primary Completion: August 24, 2022
• Study Completion: October 26, 2022
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)