International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

NCT ID: NCT03909100

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2020-02-28

Brief Summary

This study aims to generate data that conveys participant's experiences such as their overall satisfaction with the CoolSculpting® treatment for their belly and love handles. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes.

Conditions

Non-invasive Fat Reduction

Study Design

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

Study Groups

CoolSculpting® System

Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion.

Group Type: EXPERIMENTAL

CoolSculpting® System

Intervention Type: DEVICE

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

Interventions

CoolSculpting® System

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 has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
• Participant has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
• Participant has a body mass index (BMI) of 18.5 to 30. A 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 had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
• 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 is pregnant or intending to become pregnant.
• Participant is lactating or has been lactating in the past 6-9 months.
• Participant is unable or unwilling to comply with 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 an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
• Participant with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
• Participant with 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 or Raynaud's disease, or Chilblains (pernio).
• Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
• Participant with impaired peripheral circulation in the area to be treated
• Participant with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
• Participant with impaired skin sensation.
• Participant with open or infected wounds.
• Participant with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the participant's risk of bruising.
• Participant with recent surgery or scar tissue in the area to be treated.
• Participant has history of hernia in or adjacent to the treatment area(s) site.
• Participant with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
• Participant has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
• Participant is taking or has taken diet pills or supplements within the past 6 months.
• 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 diagnosed with fibrosis.

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

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Jo

Role: STUDY_DIRECTOR

Allergan

Locations

Sandhurt Plastic Surgery

Bendigo, Victoria, Australia

Academy Face and Body

Subiaco, Western Australia, Australia

Vancouver Laser & Skin Care Centre

Vancouver, British Columbia, Canada

Halley Medical Aesthetics

Singapore, , Singapore

Dr Benjamin Yim Clinical Aesthetics and Laser Centre

Singapore, , Singapore

Revere Riverside Ltd

Northwood, Middlesex, United Kingdom

Revere Clinics

London, , United Kingdom

Countries

Australia; Canada; Singapore; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CMO-MA-PLS-0602

Identifier Type: -

Identifier Source: org_study_id