Clinical trial NCT03909100: International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Official title: International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Fat Reduction
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
Secondary outcomes:
measure: Percentage of Participants Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 in Treated Area(s)
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
measure: Percentage of Participants Who Received 1 or 2 Treatments Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1 by Number of Treatment Cycles
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
measure: Percentage of Participants by Body Mass Index (BMI) Categories Who Reported "Satisfied" or "Very Satisfied" on CSQ Item #1
timeFrame: 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions)
measure: Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography
timeFrame: Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
measure: Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs)
timeFrame: First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments)
Other outcomes:
Locations:
city: Bendigo
country: Australia
facility: Sandhurt Plastic Surgery
state: Victoria
city: Subiaco
country: Australia
facility: Academy Face and Body
state: Western Australia
city: Vancouver
country: Canada
facility: Vancouver Laser & Skin Care Centre
state: British Columbia
city: Singapore
country: Singapore
facility: Halley Medical Aesthetics
city: Singapore
country: Singapore
facility: Dr Benjamin Yim Clinical Aesthetics and Laser Centre
city: Northwood
country: United Kingdom
facility: Revere Riverside Ltd
state: Middlesex
city: London
country: United Kingdom
facility: Revere Clinics
Study officials:
affiliation: Allergan
name: Esther Jo
role: STUDY_DIRECTOR
References: