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

NCT ID: NCT01976247

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2025-12-31

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.

Detailed Description

At baseline visit, subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be randomly assigned to receive Zeltiq treatment to either their right or left flank The contralateral flank will receive Liposonix treatment. A total of three identical treatments will be completed monthly for 3 consecutive months. Subjects will return 4 weeks following the last treatment for follow up photography, measurements, and assessments. This study is a pilot study designed to determine feasibility of these procedures.

Conditions

Abdominal Fat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Noninvasive Cryolipolysis Device

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

Group Type: ACTIVE_COMPARATOR

Noninvasive Cryolipolysis Device

Intervention Type: DEVICE

High Intensity Focused Ultrasound Device

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

Group Type: ACTIVE_COMPARATOR

High Intensity Focused Ultrasound Device

Intervention Type: DEVICE

Interventions

High Intensity Focused Ultrasound Device

Intervention Type: DEVICE

Noninvasive Cryolipolysis Device

Intervention Type: DEVICE

Other Intervention Names

Liposonix; Zeltiq

Eligibility Criteria

Inclusion Criteria

1. Female subjects ages 30-65 years old.

2. 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).

3. Subjects are in good health.

4. 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.

5. Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study.

6. 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.

Exclusion Criteria

1. Pregnant or lactating or intends to become pregnant in the next 9 months.

2. Unable to understand the protocol or to give informed consent.

3. Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area.

4. 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..

5. History of asthma or chronic obstructive pulmonary diseases.

6. Active skin disease or skin infection in the treatment area.

7. Bleeding tendency or coagulopathy.

8. Subjects who are allergic to lidocaine.

9. 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Murad Alam

Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Department of Dermatology

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU84032

Identifier Type: -

Identifier Source: org_study_id