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Procedure

Device Treatment for Cellulitis

N/A
Recruiting
Led By Rod Rohrich, md
Research Sponsored by InMode MD Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects aged 18-65 (inclusive)
Subject having cellulite grade 1-4 as graded using the Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial aims to test a device called Morpheus 8 Body 40-pin tip that goes up to 7mm deep in the skin. The goal is to see if it is safe and

Who is the study for?
This trial is for individuals looking to reduce the appearance of cellulite, skin laxity, and subcutaneous fat deposits. Specific eligibility criteria are not provided, but typically participants should be in good health with a clear diagnosis of cellulite.Check my eligibility
What is being tested?
The study is testing the Morpheus8 Body device with a 40-pin tip that can target up to 7mm deep under the skin. It aims to see if this treatment is safe and effective for improving cellulite, tightening skin, and reducing fat.See study design
What are the potential side effects?
While specific side effects are not listed here, similar treatments may cause temporary redness, swelling at the treatment site, bruising or tenderness. These usually resolve on their own.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged between 18 and 65.
Select...
My cellulite severity is between mild to severe, as per a doctor's evaluation.
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I agree to follow the study's rules and won't use other beauty treatments during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale
Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale
Secondary outcome measures
Investigator assessment of the cellulite following subdermal Morpheus8 treatment
Investigator assessment of the skin appearance
Investigator assessment of the skin appearance improvemen
+3 more
Other outcome measures
Adverse Event rate
Pain Scale

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device TreatmentExperimental Treatment1 Intervention
Eligible subjects will undergo two treatments with the Morpheus8 device using the 3, 5 7 mm depths or sequential (Burst) mode, based on the treating physician's discretion.

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor
23 Previous Clinical Trials
1,325 Total Patients Enrolled
Rod Rohrich, mdPrincipal Investigator
. Macrene Alexiades, mdPrincipal Investigator

Frequently Asked Questions

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

Do I meet the criteria to participate in this medical study?

"To be eligible for participation, individuals must have cellulitis and fall between the ages of 18 to 65. A total of 40 candidates will be enrolled in this research endeavor."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"Indeed, the information from clinicaltrials.gov indicates that this research study is actively seeking participants. The trial was initially posted on June 16th, 2022, and most recently revised on February 21st, 2024. It aims to recruit a total of 40 patients distributed between two designated sites."

Answered by AI

How many individuals are currently enrolled as participants in this clinical study?

"Indeed, as per details on clinicaltrials.gov, this investigation is actively seeking individuals to participate. The trial was originally listed on June 16th, 2022 and underwent its most recent modification on February 21st, 2024. A total of 40 participants will be enrolled from two different locations."

Answered by AI

Are individuals above the age of 40 being sought for participation in this research study?

"Individuals between the ages of 18 and 65 are eligible to participate in this trial based on the inclusion criteria."

Answered by AI

What are the primary objectives of this scientific study?

"The primary objective of this investigation, to be assessed over a span of 6 months, is the evaluation of cellulite utilizing the DiBernardo Photonumeric Cellulite Severity Scale. Secondary objectives consist of evaluating skin appearance improvement as per Investigator assessment using the Global Aesthetic Improvement 4-point grading scale (0=No tightening/firmness, 1=Slightly visible tightening/firmness, 2=Visible tightening/firmness, 3=Very visible tightening/firmness) during all post-treatment visits; Subject assessment through a Likert scale rated from 0 to 4 at follow-up appointments at month one,"

Answered by AI

Who else is applying?

What site did they apply to?
Dallas Plastic Surgeon
Dermatology & Laser Surgery Center of New York
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Lost weight (189 to 138) and have cellulite all over my legs and slightly in my stomach.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite
2022. "RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06283056.
All > Cellulite > Fort Worth
~0 spots leftby Jun 2024
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