Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature

NCT01600638 | Completed Results

• 1 other identifier: ZA12-005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.

Conditions

Body Fat Disorder

Keywords

Lipolysis; Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (2)

• Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.

  Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.

  8 weeks and 16 weeks post final treatment

• Change in Fat Layer Thickness When Compared to Untreated Control

  Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the contralateral untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.

  16 weeks post final treatment

Secondary Outcomes (3)

• Proportion of Pre-treatment Images Correctly Identified

  16 weeks post final treatment

• Subject Satisfaction Questionnaire

  16 weeks post final treatment

• Additional Safety Evaluation

  Enrollment though 16 weeks post final treatment

Study Arms (1)

Zeltiq System Treatment Group

EXPERIMENTAL

Individuals with sharp flank curvatures were treated on one (1) flank with the Zeltiq CoolSculpting System and the CoolCurve+ applicator at protocol-defined temperatures and durations.

Device: The Zeltiq System

Interventions

The Zeltiq System DEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Also known as: Cryolipolysis, Lipolysis

Zeltiq System Treatment Group

Eligibility Criteria

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

You may qualify if:

• Male or female subjects \> 18 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.
• Subject has not had weight change exceeding 10 pounds in the preceding month.
• Subject with body mass index (BMI) up to 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
• Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
• Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
• Subject has read and signed a 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, abdominoplasty, 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 5 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 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)

Innovation Research Center

Pleasanton, California, 94588, United States

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Results Point of Contact

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

kerrie.jiang@allergan.com

(925) 621-7462

Study Officials

• Eric Bachelor, MD

  Innovation Research Center

  PRINCIPAL INVESTIGATOR

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: April 16, 2012
• First Posted: May 17, 2012
• Study Start: March 29, 2012
• Primary Completion: August 29, 2012
• Study Completion: September 30, 2013
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)