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Radiofrequency

MorpheusV Applicator for Vulvovaginal Atrophy

N/A
Waitlist Available
Research Sponsored by InMode MD Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other treatment methods in the treated area for the last 6 months and during the entire study period.
Healthy non-smoking female subjects, > 35 and < 75 years of age at the time of enrolment post menopausal with absence of menstruation of at least 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Study Summary

This trial will test the effectiveness of the MorpheusV device in treating symptoms of vulvovaginal atrophy.

Who is the study for?
This trial is for healthy non-smoking women aged 35-75 who are postmenopausal and have symptoms of vulvovaginal atrophy. They must have a BMI under 36, not be using certain treatments in the area, and agree to follow-up visits. Those with heat-sensitive diseases, implants in the treatment area, cancer history, immune disorders, or severe health conditions cannot participate.Check my eligibility
What is being tested?
The study tests the MorpheusV Applicator on women with vulvovaginal atrophy. Participants will receive three treatments four weeks apart and attend follow-ups at 3, 6, and 12 months after treatment. The goal is to see if this device can alleviate symptoms over a year-long period.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may cause temporary redness, swelling or discomfort at the treatment site. There's also a risk of burns due to radio-frequency energy if not used correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to follow the study's schedule and not use other treatments in the study area.
Select...
I am a healthy woman, aged 35-75, a non-smoker, and have not had a period for at least 12 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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
Assess the degree of difficulty encountered by the physician in performing the treatment
Assess the effect of treatment on the general quality of life
The effect of the treatment on Sexual Function
+4 more
Secondary outcome measures
Adverse events
Discomfort scale
Occurrence of expected post-treatment adverse events

Trial Design

1Treatment groups
Experimental Treatment
Group I: treatmentExperimental Treatment1 Intervention
3 treatments once a month
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MorpheusV Applicator
2021
N/A
~50

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor
23 Previous Clinical Trials
1,335 Total Patients Enrolled

Frequently Asked Questions

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

Who can enroll in this research endeavor?

"Eligibility criteria for this medical trial entails atrophic participants aged between 35 and 75, with the aim to enroll a total of 30 candidates."

Answered by AI

Are individuals being recruited for this research program at present?

"Clinical trials.gov details that this clinical trial is currently looking for volunteers to participate in the study, which was first launched on September 1st 2021 and last modified on May 25th 2022."

Answered by AI

May adults aged eighteen and above partake in this clinical investigation?

"For this particular trial, the age range is between 35 and 75 years old. There are 42 trials for participants younger than 18, and 140 trials available to those above 65."

Answered by AI

What is the magnitude of participants in this trial?

"Affirmative. The records available on clinicaltrials.gov suggest that this experiment, whose initiation dates back to September 1st 2021, is currently enrolling patients. At least 30 participants will be recruited between 2 hospital locations."

Answered by AI

Who else is applying?

What site did they apply to?
Beyond Regenerative Medicine and Aesthetics
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have been using Imvexxy but would like to see if there is something better I could use.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy
2021. "Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05398172.
All > Vaginal Atrophy
~8 spots leftby Apr 2025
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