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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour at baseline and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour at baseline and week 12
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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of asthma or chronic lung diseases that affect your breathing.You are allergic to lidocaine.The study includes female participants between the ages of 30 and 65 years old.The subjects are healthy and in good condition.Subjects will maintain their weight by not making any changes to their diet or lifestyle during the study.You have a healthy weight based on your height and weight measurements.Willing and able to not take part in any other treatments - including those already being taken or new ones - to promote body contouring and/or weight loss during the course of study participation.You should be in overall good health.
Research Study Groups:
This trial has the following groups:- Group 1: High Intensity Focused Ultrasound Device
- Group 2: Noninvasive Cryolipolysis Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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