CoolSculpting® Elite for Non-Invasive Fat Reduction

NCT ID: NCT04897867

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2022-06-15

Brief Summary

This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.

Conditions

Non-invasive Fat Reduction

Study Design

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

Study Groups

CoolSculpting® Elite System

Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs.

Group Type: EXPERIMENTAL

CoolSculpting® Elite System with CoolSculpting® Elite applicators

Intervention Type: DEVICE

A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.

Interventions

CoolSculpting® Elite System with CoolSculpting® Elite applicators

A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Participant must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
• Participant has clearly visible and palpable fat in the abdomen and flanks, and participant may also be assessed for visible and palpable fat in one or more of the following body areas: left and right lower aspects of the upper arms, left and right inner thigh, left and right outer thigh, or submental area, which in the investigator's opinion is appropriate for and may benefit from treatment.
• Participant has a BMI of ≥ 18.5 and < 30. BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
• Participant agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
• Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria

• Participant has a history of an invasive fat reduction procedure (eg, liposuction, surgery, lipolytic agents, etc) within or adjacent to the area being considered for treatment.
• Participant has implants (eg, breast implants) in or immediately adjacent to the area of intended treatment.
• Participant has a history of prior surgery or scar tissue related to the area being considered for treatment.
• Participant has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
• Participant has a known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin, such as cold urticaria, Raynaud's disease, or chilblains (pernio).
• Participant with a clinically significant bleeding disorder, or concomitant use of blood thinners, or is taking any medication that, in the investigator's opinion, may significantly increase the participant's risk of bruising or bleeding.
• Participant has a history of carpal tunnel syndrome, compartment syndrome, or deep vein thrombosis in the upper or lower extremities (only applicable for participants receiving treatment to the upper arms or thighs).
• Participant is currently taking or has taken diet pills or weight control supplements within the past 6 months.
• Participant has any skin conditions, such as moderate to excessive skin laxity, open wound, or scars, and active infection, eczema, dermatitis or rashes in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks are not an exclusion).
• Participant has an active implanted device such as a pacemaker, defibrillator, drug delivery system, or any other metal-containing implant, within or adjacent to the area being considered for treatment.
• Participant (WOCBP- woman of childbearing potential) is pregnant or intending to become pregnant in the next 3 to 6 months and does not agree to use reliable contraception during the study.
• Participant is lactating or has been lactating in the past 6 months.
• Participant is unable or unwilling to comply with the study requirements.
• Participant is currently enrolled in a clinical study of any unapproved investigational device, investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study.
• Participant has any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the participant's response or the integrity of the data or would pose an unacceptable risk to the participant.
• Participant has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
• Participant needs to administer, or has a known history of subcutaneous injections, into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
• Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
• Participant has impaired peripheral circulation in the area to be treated.
• Participant has neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
• Participant has impaired skin sensation in or immediately adjacent to the treatment area(s).
• Participant has a history of hernia in or immediately adjacent to the treatment area(s).
• Participant diagnosed with a systemic fibrosing disease or fibrosis in the area intended or adjacent to the area to be treated.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ALLERGAN INC.

Role: STUDY_DIRECTOR

Allergan

Locations

Laser & Skin Surgery Medical group, Inc /ID# 239112

Sacramento, California, United States

Cosmetic Laser Dermatology /ID# 239110

San Diego, California, United States

Cosmetic Laser Dermatology /ID# 239111

San Diego, California, United States

Laser & Skin Surgery Center of New York /ID# 239113

New York, New York, United States

Centre Laser International de la Peau /ID# 239117

Paris, , France

Bodenseeklinik /Id# 239155

Lindau, , Germany

Halley Medical Aesthetics /ID# 239124

Singapore, , Singapore

Akademikliniken /ID# 239120

Stockholm, , Sweden

Countries

United States; France; Germany; Singapore; Sweden

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MED-MA-PLS-0647

Identifier Type: -

Identifier Source: org_study_id