Ultrasound Device and Cryolipolysis Device for Abdominal Obesity

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Northwestern University

Must not be taking: Diet pills

Disqualifiers: Pregnancy, Asthma, Skin disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

15 Participants Needed

Trial Summary

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 data supports the effectiveness of this treatment for abdominal obesity?

Research shows that high-intensity focused ultrasound (HIFU) and cryolipolysis are effective noninvasive treatments for reducing localized fat, such as in the abdomen, by targeting and breaking down fat cells without surgery. ^{1 2 3 4 5}

Is the combination of ultrasound and cryolipolysis safe for reducing abdominal fat?

Studies show that high-intensity focused ultrasound (HIFU) and cryolipolysis are generally safe for fat reduction, with side effects like temporary tenderness, bruising, and swelling. The combination of these treatments is also considered safe and well-tolerated. ^{1 2 6 7 8}

How does the ultrasound and cryolipolysis treatment for abdominal obesity differ from other treatments?

This treatment is unique because it combines high intensity focused ultrasound, which uses sound waves to disrupt fat cells, with cryolipolysis, a method that cools fat cells to destroy them. Both methods are noninvasive, meaning they do not require surgery, and they target fat cells specifically, sparing other tissues. ^{9 10 11 12 13}

What is the purpose of this 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.

Research Team

Murad Alam, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

Subjects agree to maintain their weight (i.e. within 5 pounds) by not making any changes to diet or lifestyle during the study

Female subjects ages 30-65 years old

The study includes female participants between the ages of 30 and 65 years old.

Exclusion Criteria

You have a history of asthma or chronic lung diseases that affect your breathing.

You are allergic to lidocaine.

Any previous and/or pending procedures at the treatment area or that may likely affect the treatment area

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive three monthly treatments with either the Zeltiq or LipoSonix system

12 weeks

3 visits (in-person)

Follow-up

Participants return for follow-up photography, measurements, and assessments

4 weeks

1 visit (in-person)

Treatment Details

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.

Participant Groups

Group I: High Intensity Focused Ultrasound Device Active Control 1 Intervention

The LipoSonix System is a noninvasive ultrasound device, which can be used to selectively target and destroy fat tissue located deep under the skin.

Group II: Noninvasive Cryolipolysis Device Active Control 1 Intervention

The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a novel device, high-intensity focused ultrasound with a contact cooling for subcutaneous fat reduction. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of a focused ultrasound device for treatment of adipose tissue in subjects undergoing abdominoplasty: a placebo-control pilot study. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Broad overview of a clinical and commercial experience with CoolSculpting. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Improvement in abdominal and flank contouring by a novel adipocyte-selective non-contact radiofrequency device. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

New waves for fat reduction: high-intensity focused ultrasound. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Global Expert Opinion on Cryolipolysis Treatment Recommendations and Considerations: A Modified Delphi Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

High-intensity focused ultrasound treatment after cryolipolysis may be used to reduce pain: Two case report. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Mouse model of selective cryolipolysis. [2023]

10. Australia pubmed.ncbi.nlm.nih.gov

Ultrasound cavitation versus cryolipolysis for non-invasive body contouring. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

An Analysis of Marketing Trends for the Approval of Cryolipolysis Devices by the United States Food and Drug Administration. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Clinical study to evaluate the performance of a noninvasive focused ultrasound device for thigh fat and circumference reduction compared to control. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Operator independent focused high frequency ISM band for fat reduction: porcine model. [2021]