A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction

NCT01976247 | Active Not Recruiting Phase 1 DMC FDA Device

• 1 other identifier: STU84032
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the safety and effectiveness of the Zeltiq System and LipoSonix System for fat reduction and improving body shape.

Conditions

Abdominal Fat

Outcome Measures

Primary Outcomes (1)

• Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12

  The primary outcome was a blinded rating of the treatment area (Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device) with the best cosmetic appearance. A dermatologist will blindly evaluate the treated areas of each side from live subjects at baseline and on the final follow up visit (week 12).

  1 hour at baseline and week 12

Study Arms (2)

Noninvasive Cryolipolysis Device

ACTIVE COMPARATOR

The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart.

Device: Noninvasive Cryolipolysis Device

High Intensity Focused Ultrasound Device

ACTIVE COMPARATOR

The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin.

Device: High Intensity Focused Ultrasound Device

Interventions

High Intensity Focused Ultrasound Device DEVICE

Also known as: Liposonix

High Intensity Focused Ultrasound Device

Noninvasive Cryolipolysis Device DEVICE

Also known as: Zeltiq

Noninvasive Cryolipolysis Device

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects ages 30-65 years old.
• Body mass index (BMI) between 18 and 29.99. (BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches).
• Subjects are in good health.
• Willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
• Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.
• The subjects have the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

You may not qualify if:

• Pregnant or lactating or intends to become pregnant in the next 9 months.
• Unable to understand the protocol or to give informed consent.
• Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area.
• Pending and/or anticipated major change in diet or exercise pattern in the six weeks following the last treatment or who has taken diet pills within the last 6 months..
• History of asthma or chronic obstructive pulmonary diseases.
• Active skin disease or skin infection in the treatment area.
• Bleeding tendency or coagulopathy.
• Subjects who are allergic to lidocaine.
• Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

US (1)