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

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01976247
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
110
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: High Intensity Focused Ultrasound Device
  • Device: Noninvasive Cryolipolysis Device
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial
Study Start Date :
Oct 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Device: Noninvasive Cryolipolysis Device
Other Names:
  • Zeltiq

    		•
    Active Comparator: 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.

    Device: High Intensity Focused Ultrasound Device
    Other Names:
  • Liposonix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12 [1 hour at baseline and 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Department of Dermatology Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Murad Alam, MD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT01976247
    Other Study ID Numbers:
    • STU84032
    First Posted:
    Nov 5, 2013
    Last Update Posted:
    Jan 5, 2022
    Last Verified:
    Jan 1, 2022

    Study Results

    No Results Posted as of Jan 5, 2022