A Pilot Study Testing a Noninvasive Cryolipolysis Device Versus a High Intensity Focused Ultrasound Device for Fat Reduction
Running, not enrolling · Phase 1
Conditions studied: Abdominal Fat
In brief
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.
Key facts
- Study ID
- NCT01976247
- Run by
- Northwestern University
- People needed
- 15
- Starts
- 2013-10-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-07-01
Who can join
Age: 30 and older, up to 65. Sex: female. Healthy volunteers: accepted.
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.
Where it is running
- Northwestern University Department of Dermatology — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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