Bilateral; Flank Study With Crown Cooling Insert

NCT ID: NCT02554760

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-15
• Study Completion Date: 2015-12-17

Brief Summary

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.

Detailed Description

This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.

Conditions

Body Fat Disorder

Study Design

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

Study Groups

All Study Participants

This is a split body study in which all subjects will receive bilateral flank treatment with CoolSculpting. The investigator will determine one flank for treatment using the CoolCore applicator without an accessory for a duration of 60 minutes at a protocol-defined temperature. The contralateral flank will be treated with the standard CoolCore Applicator using an applicator accessory, the Crown Cooling Insert (CCI) at a protocol-defined temperature for a duration of up to 45 minutes. All enrolled subjects receive identical treatments; the investigator will use alternate subject numbers to balance which flank to treat with and without the CoolCore applicator accessory, such that all even subject numbers will receive treatment using the Standard CoolCore on the right flank and odd subject numbers will receive the same treatment on the left flank.

Group Type: EXPERIMENTAL

The ZELTIQ CoolSculpting System

Intervention Type: DEVICE

The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the treatments.

Interventions

The ZELTIQ CoolSculpting System

The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the 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 on the flanks, which in the investigator's opinion, may benefit from the treatment.
• No weight change exceeding 5% of body weight in the preceding month.
• Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
• Subject agrees to maintain his/her weight (i.e., within 5%) 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

• Subject has had a surgical procedure(s) in the area of intended treatment.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, 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 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).
• 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 has a history of hernia in the areas to be treated.
• 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.

• 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

Suzanne Kilmer, MD

Role: PRINCIPAL_INVESTIGATOR

Laser and Skin Surgery Center of Northern California

Locations

Laser and Skin Surgery of Northern California

Sacramento, California, United States

Countries

United States

References

Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.

Reference Type: RESULT

PMID: 27327898 (View on PubMed)

Other Identifiers

ZA15-004

Identifier Type: -

Identifier Source: org_study_id