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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post treatment follow-up visit
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a device called the SofWave System to treat patients' upper thighs and/or buttocks. The device sends energy into the skin to improve its appearance or health.
Eligible Conditions
- Cellulite
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post treatment follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post treatment follow-up visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CelluliteExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sofwave
2020
Completed Phase 3
~240
Find a Location
Who is running the clinical trial?
Sofwave Medical LTDLead Sponsor
9 Previous Clinical Trials
512 Total Patients Enrolled
1 Trials studying Cellulite
69 Patients Enrolled for Cellulite
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of skin disorders that affect the collagen or blood vessels in your body.You smoke a lot, at least 25 cigarettes a day, or have smoked heavily in the last 10 years.You have a body mass index (BMI) of 30 or higher, which means you are overweight or obese.You are currently taking medication for mental health conditions.You want to get rid of cellulite on your upper thighs and/or buttocks.You have a history of severe migraines.You have a history of long-term drug or alcohol abuse.You have a history of bleeding problems or are taking medication that could make you more likely to bruise.You have a medical condition that could delay healing or weaken your immune system, like a blood disorder or inflammatory disease.You have allergies to lidocaine, epinephrine, or antibiotics.You have a history of serious issues with your lymphatic system.You have skin problems like infections, rashes, or scarring in the area where the treatment will be applied.You have a tattoo or previous tattoo near the area where the treatment will be given.You have noticeable scarring or a history of scars that heal poorly, and you easily get bruises.You have visible dimples or bumps on your thighs or buttocks.You are currently using or have used diet pills or weight control supplements in the last month.You have a history of seizures or epilepsy.You have a history of blood clotting disorders or are taking medication to prevent blood clots.
Research Study Groups:
This trial has the following groups:- Group 1: Cellulite
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.
Cellulite Patient Testimony for trial: Trial Name: NCT05882721 — N/A
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