- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01976247
A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction
March 14, 2024 updated by: Murad Alam, Northwestern University
Pilot Study Comparing the Effectiveness of a Noninvasive Cryolipolysis Device vs. a High Intensity Focused Ultrasound Device for Fat Reduction: A Randomized Control Trial
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Department of Dermatology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Other Names:
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12
Time Frame: 1 hour at baseline and week 12
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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).
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1 hour at baseline and week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Murad Alam, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 15, 2013
First Submitted That Met QC Criteria
October 29, 2013
First Posted (Estimated)
November 5, 2013
Study Record Updates
Last Update Posted (Actual)
March 18, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- STU84032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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