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Ultrasound Therapy

Ultrasound Device and Cryolipolysis Device for Abdominal Obesity

N/A
Waitlist Available
Led By Murad Alam, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour at baseline and week 12
Awards & highlights

Study Summary

This trial will compare two systems for fat reduction and improving body shape.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, redness, bruising, swelling, tingling sensations during recovery. The intensity of these side effects can vary based on individual reactions to each device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour at baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour at baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in best overall cosmetic appearance (right side or left side better)rated by a blinded dermatologist from baseline to week 12

Trial Design

2Treatment groups
Active Control
Group I: High Intensity Focused Ultrasound DeviceActive Control1 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 DeviceActive Control1 Intervention
The Zeltiq System is a noninvasive (not breaking the skin) device that reduces fat by freezing fat cells until they break apart.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,216 Total Patients Enrolled
Murad Alam, MDPrincipal InvestigatorNorthwestern University
69 Previous Clinical Trials
2,565 Total Patients Enrolled

Media Library

High Intensity Focused Ultrasound Device (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01976247 — N/A
Abdominal Obesity Research Study Groups: High Intensity Focused Ultrasound Device, Noninvasive Cryolipolysis Device
Abdominal Obesity Clinical Trial 2023: High Intensity Focused Ultrasound Device Highlights & Side Effects. Trial Name: NCT01976247 — N/A
High Intensity Focused Ultrasound Device (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01976247 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Northwestern University Department of Dermatology
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Dec 2024