Freeze or melt? study pits two Fat-Reduction devices Head-to-Head
NCT ID NCT01976247
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This pilot study compares two noninvasive devices—one that freezes fat (cryolipolysis) and one that uses ultrasound energy—to see which works better for reducing belly fat and improving body shape. About 15 healthy women aged 30 to 65 with a normal or slightly overweight body mass index will receive both treatments on opposite sides of their abdomen. A blinded dermatologist will rate cosmetic improvement at 12 weeks to determine which device provides better results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Noninvasive cryolipolysis device (Zeltiq) and high-intensity focused ultrasound device (Liposonix)
- What this could lead to
- If one device proves more effective, it could offer a better non-surgical option for fat reduction.
- What could go wrong
- This is a small, early-phase pilot study with only 15 participants, so results may not apply to everyone. Both devices may cause temporary side effects like bruising or discomfort.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Oct 2013
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 65 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University Department of Dermatology
Chicago, Illinois, 60611, United States
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