Ultrasound Device and Cryolipolysis Device for Abdominal Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two noninvasive treatments: the LipoSonix System, a high-intensity focused ultrasound device, and the Zeltiq System, a noninvasive cryolipolysis device. The goal is to determine which is safer and more effective for reducing belly fat and improving body shape. The LipoSonix System uses ultrasound to target and destroy fat tissue, while the Zeltiq System freezes fat cells until they break apart. Women aged 30 to 65, with a BMI between 18 and 29.99, who are in good health and can maintain stable weight and lifestyle during the study, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatments work in people, offering participants the opportunity to be among the first to receive these innovative treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not start any new treatments for body contouring or weight loss during the study.
What prior data suggests that these devices are safe for fat reduction?
Research has shown that both High Intensity Focused Ultrasound (HIFU) and Noninvasive Cryolipolysis (fat-freezing) are generally safe for reducing fat.
For HIFU, studies indicate it is usually safe and effective. Some individuals might experience mild side effects like temporary redness or swelling, but these effects are short-lived and not serious.
The fat-freezing method is also considered safe. The FDA has approved it for fat reduction. Clinical studies report it can reduce fat safely, with rare and manageable complications.
Both treatments have undergone safety testing and are well-tolerated by most individuals.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for abdominal obesity because they offer noninvasive alternatives to traditional methods like liposuction. The High Intensity Focused Ultrasound Device, known as the LipoSonix System, uses targeted ultrasound waves to selectively destroy fat tissue deep under the skin without surgery. Meanwhile, the Noninvasive Cryolipolysis Device, or Zeltiq System, reduces fat by freezing fat cells until they break apart, also without breaking the skin. These treatments are distinctive because they avoid invasive procedures, potentially reduce recovery time, and provide a more comfortable experience for patients looking to reduce abdominal fat.
What evidence suggests that these devices are effective for abdominal obesity?
This trial will compare the effectiveness of two noninvasive treatments for abdominal obesity: a High Intensity Focused Ultrasound Device and a Noninvasive Cryolipolysis Device. Studies have shown that high-intensity focused ultrasound (HIFU) effectively reduces fat. Research indicates that it can safely target and destroy fat cells under the skin, leading to a noticeable reduction in fat. A recent review of multiple studies reports that HIFU treatments can help reduce waist size and overall fat. Meanwhile, cryolipolysis, or fat freezing, has proven effective in reducing fat in areas like the belly and thighs. Specifically, one study found a significant reduction in belly fat, showing a decrease of about 4.1 kg. Both treatments are noninvasive and have shown positive results in reducing fat, making them promising options for fat reduction.35678
Who Is on the Research Team?
Murad Alam, MD
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
This trial is for healthy women aged 30-65 with a BMI between 18 and 29.99, who are not pregnant or breastfeeding, have no history of severe lung diseases or allergies to lidocaine, and haven't had recent treatments that could affect body shape. Participants must maintain their current weight and lifestyle without any new diet or exercise changes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three monthly treatments with either the Zeltiq or LipoSonix system
Follow-up
Participants return for follow-up photography, measurements, and assessments
What Are the Treatments Tested in This Trial?
Interventions
- High Intensity Focused Ultrasound Device
- Noninvasive Cryolipolysis Device
Trial Overview
The study compares two fat reduction devices: the Zeltiq System (Cryolipolysis) versus the LipoSonix System (High Intensity Focused Ultrasound). It aims to determine which device is safer and more effective in improving body shape by reducing abdominal fat.
How Is the Trial Designed?
2
Treatment groups
Active Control
The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin.
The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Citations
Experimental evaluation of high intensity focused ...
The present study was stimulated by the continuous growth of commercially available high intensity focused ultrasound (HIFU) systems for fat reduction.
Ultrasound and high frequency equipment efficacy for ...
The results demonstrated significant changes in several key metrics of abdominal obesity (Table 1). Table 1 summarizes the detailed data for ...
Review of high-intensity focused ultrasound for lipolysis
A recent meta-analysis of the outcome of non-invasive fat removal suggests that HIFU may positively lead to weight loss and wasit circumference reduction in the ...
High‐intensity focused ultrasound treatment for excessive ...
The results from the present study indicate HIFU can be an effective and safe therapeutic modality for removing excessive subcutaneous fat in humans.
Early and Long-Term Effects of Abdominal Fat Reduction ...
However, newer devices are more effective; in one study, a reduction in thigh circumference of 2.43 cm after only four weekly treatments was ...
Numerical study of high‐intensity focused ultrasound (HIFU ...
A number of articles have reported the safety and efficacy of HIFU over other similar treatments, such as the use of lasers ; however, in practice, side effects ...
Complications and Risks of High-Intensity Focused ...
The findings confirm that HIFU is generally safe and effective, with most complications being mild and transient, such as temporary erythema, swelling, and ...
32-7-868.pdf
Objectives: The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. Methods: Adults with subcutaneous abdominal fat ≥ ...
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