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Electrohydraulic Device
Rapid Acoustic Pulse Therapy for Cellulite
Phase 4
Recruiting
Research Sponsored by Zeltiq Aesthetics
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 72 weeks
Awards & highlights
Study Summary
This trial will assess the safety & effectiveness of RAP device for treatment of cellulite in adults. Participants will have 3 treatments and be monitored for up to 72 weeks.
Who is the study for?
Adults aged 18-50 with moderate to severe cellulite on thighs or buttocks can join this trial. They shouldn't have had any tanning treatments, invasive cellulite procedures, or used topical cellulite treatments for the past 3 months. Those with metal/plastic implants, electronic devices like pacemakers, blood clotting issues, skin disorders in the area, or recent surgeries are excluded.Check my eligibility
What is being tested?
The Rapid Acoustic Pulse (RAP) device is being tested for its effectiveness in improving the appearance of cellulite on the thighs and buttocks. Participants will undergo three treatment sessions and be monitored over a period of up to 72 weeks through medical assessments and questionnaires.See study design
What are the potential side effects?
Potential side effects may include discomfort at the treatment site, bruising, swelling, redness or changes in skin sensation. The study aims to assess these adverse events thoroughly during regular clinic visits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events
Percentage of Participants with Improvement in the Appearance of Cellulite as Determined by Blinded Independent Physician Reviewers (IPR)
Secondary outcome measures
Percentage of Participants with "Agree" or "Strongly Agree" Responses to the Participant Satisfaction Survey in the Improvement in Appearance of Cellulite
Trial Design
1Treatment groups
Experimental Treatment
Group I: Rapid Acoustic Pulse (RAP)Experimental Treatment1 Intervention
Participants will receive 3 separate RAP cellulite treatments sessions.
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Who is running the clinical trial?
Zeltiq AestheticsLead Sponsor
40 Previous Clinical Trials
1,834 Total Patients Enrolled
3 Trials studying Cellulite
134 Patients Enrolled for Cellulite
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have significant cellulite on your thighs and/or buttocks, rated as grades 2 or 3 based on photos taken in similar lighting conditions to those used in the trial.I haven't used any cellulite creams for the last 3 months and won't use them during the trial.I haven't used spray-on tans for the last 3 months and won't during the trial.I haven't had surgery in the treatment area in the last 3 months and don't plan to during the study.I do not have any health conditions that could affect wound healing or my immune system.You have metal or plastic implants in the areas where the treatment will be given.I have a blood clotting disorder or am on blood thinners.I have skin conditions like infections, rashes, or psoriasis in the areas to be treated.I haven't had any cellulite treatments like surgery or energy-based procedures in the past year.I haven't used spray-on tans for the last 3 months and won't use them during the trial.You have noticeable cellulite on your thighs and/or buttocks, rated as grades 2 or 3 based on photos taken in the same lighting conditions planned for the study.I want treatment for cellulite on my thighs or buttocks.I haven't had any cellulite treatments like liposuction or laser in the past year.I want treatment for cellulite on my thighs or buttocks.
Research Study Groups:
This trial has the following groups:- Group 1: Rapid Acoustic Pulse (RAP)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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: NCT05664581 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial open to elderly populations over 75 years old?
"In line with the study's standards, only persons aged 18 and above but not exceeding 50 are eligible for participation."
Answered by AI
Am I eligible to enroll in this research project?
"To enroll in this clinical trial, eligible participants must possess cellulite and be between 18-50 years of age. The total number of candidates accepted is capped at 15 people."
Answered by AI
Is this research trial presently enrolling participants?
"The clinical trial is still in progress, as evidenced by the data on clinicaltrials.gov which reveals that it was first posted on December 14th 2022 and last edited a day later."
Answered by AI
What is the cap on participant enrollment for this clinical experiment?
"Affirmative. By consulting clinicaltrials.gov, we can see that this trial is still recruiting participants following its initial posting on December 14th 2022 and most recent update on the 15th of the same month. A total of fifteen people are needed to be assessed across one site."
Answered by AI
Does RAP pose a hazard to those exposed?
"There is ample evidence that Rapid Acoustic Pulse (RAP) carries a low risk of side-effects, which has earned it a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Wisconsin
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
What site did they apply to?
Innovation Research Center
Why did patients apply to this trial?
Think I might be a good candidate. I'm hoping that the clinical trial will help with my cellulite.
PatientReceived no prior treatments
I have more cellulite since menopause and would love to get rid of it! I cannot get rid of the cellulite and hoping that this study can help me with that.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long will the treatment last? How long are the visits? Is there anything closer? How many visits are required and is cost of travel compensated?
PatientReceived 2+ prior treatments
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