CoolSculpting the Flanks

NCT03304925 | Unknown FDA Device

• 1 other identifier: ZA17-002
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 7

Brief Summary

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• Safety endpoint in relation to adverse events

  Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs

  Final post treatment visit

• Effectiveness endpoint gauged by reduction in fat layer thickness

  Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.

  Final post-treatment visit

Secondary Outcomes (2)

• Subject survey

  Final post-treatment visit

• Photo review

  Final post-treatment visit

Study Arms (1)

Fat Reduction

EXPERIMENTAL

The treatments are designed to see if the fat can be reduced in the flanks 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:

• Male or female subjects \> 22 years of age and \< 65 years of age.
• Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
• No weight change exceeding 5% of body weight in the preceding month.
• Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
• 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 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, 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
• 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 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 (7)

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

SkinCare Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, 02467, United States

Location

Zel Skin & Laser Specialist

Edina, Minnesota, 55424, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Brian S. Biesman, MD

Nashville, Tennessee, 37203, United States

Location

EpiCenter Skincare and Laser Center

Dallas, Texas, 95231, United States

Location

Study Officials

• Kerrie Jiang, NP

  Zeltiq Aesthetics

  STUDY DIRECTOR

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 3, 2017
• First Posted: October 9, 2017
• Study Start: October 25, 2017
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)