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MorpheusV Applicator for Vulvovaginal Atrophy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vulvovaginal AtrophyMorpheusV Applicator - Device
Eligibility
35 - 75
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Vulvovaginal Atrophy

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

7 Primary · 3 Secondary · Reporting Duration: up to 12 months

baseline through 12 months
Adverse events
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
The effect of the treatment on urinary symptoms
The rate of satisfaction of patients with treatment
effect of treatment on VVA symptoms
objective evaluation of vaginal atrophy/estrogenization
up to 12 months
Occurrence of expected post-treatment adverse events
up to 3 months
Discomfort scale

Trial Safety

Safety Progress

1 of 3

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1
AAV2-GDNF gene therapy
1
[18F]UCB-2897
1
AAV2-GDNF

Trial Design

1 Treatment Group

treatment
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: MorpheusV Applicator · No Placebo Group · N/A

treatment
Device
Experimental Group · 1 Intervention: MorpheusV Applicator · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MorpheusV Applicator
2021
N/A
~50

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor
18 Previous Clinical Trials
1,142 Total Patients Enrolled

Eligibility Criteria

Age 35 - 75 · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have signed an informed consent to participate in the study.
You have a VHIS<15.
You are between 35 and 75 years of age at the time of enrolment
References

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