Feasibility of Producing the Appearance of a Gluteal Lift Post Cryolipolysis

NCT04553627 | Unknown FDA Device

• 1 other identifier: Allergan IIT-2019-10713
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of cryolipolysis of the medial infragluteal fold to create the appearance of a gluteal lift.

Conditions

Subcutaneous Fat

Keywords

reduction

Outcome Measures

Primary Outcomes (3)

• Incidence of treatment-emergent Adverse Events [Safety and Tolerability]

  The primary endpoint of the study is to evaluate the safety of subcutaneous fat reduction in the medial intragluteal folds using the ZELTIQ System as a non-invasive clinical treatment. Safety will be measured through the incidence of device and/or procedure-related adverse event.

  12 weeks

• Subjective clinical evaluation of subcutaneous fat treatment by Cryolipolysis [Efficacy]

  The primary endpoint of the study is to evaluate the efficacy of subcutaneous fat reduction in the medial intragluteal folds using the ZELTIQ System as a non-invasive clinical treatment. This will be evaluated by two blinded independent reviewers through the review of pre-treatment vs. post-treatment photos taken with a VECTRA H2 (Canfield Scientific, Inc) camera.

  12 weeks

• Aggregated measurements of subcutaneous fat treatment by Cryolipolysis [Efficacy]

  The primary endpoint of the study is to evaluate the efficacy of subcutaneous fat reduction in the medial intragluteal folds using the ZELTIQ System as a non-invasive clinical treatment. Quantitative measurements of efficacy will be determined by review of 3-D images from a Vectra H2 software by Canfield Scientific, Inc. measuring buttock volume difference in cc, angle formed at the inner gluteal vertex in degrees, and Height difference from the top to the bottom of the buttock in mm and surface area reduction calculations in cm2

  12 weeks

Secondary Outcomes (1)

• Subject satisfaction of subcutaneous fat treatment documented in written questionnaire

  12 weeks

Study Arms (1)

Interventional cohort

EXPERIMENTAL

Zeltiq system is a thermoelectric device that applies controlled cooling ot skin. The CoolAdvantage applicators use gentle vacuum pressure to draw tissue into the cup shaped applicator. A gelpad is applied to skin to improve thermal coupling between participant and the applicator cooling surface.

Device: ZELTIQ thermoelectric device

Interventions

ZELTIQ thermoelectric device DEVICE

This is a feasibility study to determine if cryolipolysis in this area produces a desirable lifted appearance to the buttocks. Typically, a lifted more youthful appearance is obtained through surgical means. Study participants will be recruited from the population of patients who have suitable, treatable subcutaneous fat on the medial infragluteal folds and desire a lifted appearance. Subjects will receive treatments with a cooled cup cryolipolysis applicator from the CoolAdvantage family of applicators (cooled cup vacuum applicator). Treatments will be performed with a treatment temperature of - 11°C for up to 35 minutes. Subjects will complete all study-required follow-up visits, including an 8-week follow-up which may include a second treatment session, as well as a 12-week post final treatment follow-up visit

Interventional cohort

Eligibility Criteria

• Age: 22 Years - 50 Years
• Gender Eligibility Details: Female subjects \> 22 years of age and \< 50 years of age will be selected for this feasibility assessment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects \> 22 years of age and \< 50 years of age.
• Presence of suitable treatable subcutaneous fat on the medial infragluteal folds, which in the investigator's opinion may benefit from CoolSculpting to potentially create a lifted appearance to the buttocks.
• BMI under 30.
• No weight change exceeding 5% of body weight in the preceding month.
• Agreement to maintain their weight (i.e., within 5%) by not making any major changes in their diet or lifestyle during the course of the study.
• Subject has read and signed a written informed consent form

You may not qualify if:

• Subject has skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
• Subject has had a surgical procedure(s) in the area of intended treatment.
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
• 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.
• 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.
• 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.
• Subject has a history of hernia in the areas to be treated.
• 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.

Sponsors & Collaborators

• Riverchase Dermatology: lead
• Allergan: collaborator

Study Sites (1)

Riverchase Dermatology

Miami, Florida, 33133, United States

Location

Study Officials

• Leyda R Bowes, MD

  Riverchase Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: September 17, 2020
• Study Start: July 15, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: May 2021 for one year
• Access Criteria: Direct request to team contact listed in Ct.gov

Locations

US (1)