CoolSculpting Treatment in the Upper Arms

NCT ID: NCT02939105

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-02
• Study Completion Date: 2017-03-03

Brief Summary

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.

Detailed Description

Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.

Conditions

Body Fat Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CoolSculpting Treatment in the Upper Arm

Subjects in the study were treated with the CoolSculpting System with one of two vacuum applicator types for bilateral fat reduction in the upper arms. Applicators were used concurrently, with an applicator on each arm. Each subject received 1 or 2 cooling cycles on each arm for 35 minutes at protocol-defined temperatures.

The Investigator selected the applicator for each subject based on the intended fat volume of the treatment area.

Group Type: EXPERIMENTAL

The ZELTIQ CoolSculpting System

Intervention Type: DEVICE

The CoolSculpting device will be used to perform treatments.

Interventions

The ZELTIQ CoolSculpting System

The CoolSculpting device will be used to perform treatments.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female subjects > 22 years of age and < 65 years of age.
• Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
• No weight change exceeding 5% in the preceding month.
• Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) 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.

Exclusion Criteria

• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
• History of prior surgery in the arms.
• Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
• Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• Pregnant or intending to become pregnant in the next 5 months.
• Lactating or has been lactating in the past 6 months.
• Unable or unwilling to comply with the study requirements.
• 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Rivers, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Dermaesthetics

Locations

Pacific Dermaesthetics

Vancouver, British Columbia, Canada

Countries

Canada

References

Rivers JK, Ulmer M, Vestvik B, Santos S. A customized approach for arm fat reduction using cryolipolysis. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22811. Online ahead of print.

Reference Type: RESULT

PMID: 29566270 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ZA16-005

Identifier Type: -

Identifier Source: org_study_id