CoolSculpting System

Not Applicable

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: The ZELTIQ System

• Registration Number: NCT04506307
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-13
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-10
• Primary Completion: 2022-08-24
• Study Completion: 2022-10-26
• Status Verified: 2025-02
• Results First Submitted: 2025-02-21
• Results First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Results First Posted: 2025-03-10
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fat Reduction	The ZELTIQ System	The treatments are designed to see if the fat can be reduced in the torso area with a new applicator design.

Primary Outcome Measures

Name	Time	Method
Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel	Week 12 post final treatment (18 weeks after first treatment)	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.

Secondary Outcome Measures

Name	Time	Method
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)	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.

Trial Locations

Locations (4)

Riverchase Dermatology; 🇺🇸 Miami, Florida, United States

Leyda E Bowes MD; 🇺🇸 Pleasanton, California, United States

Moradi MD Cosmetic Surgery; 🇺🇸 Vista, California, United States

Marina Plastic Surgery; 🇺🇸 Marina Del Rey, California, United States