NCT05398172

Clinical Evaluation of Fractional Bi-Polar Radio-Frequency for Symptoms of Vulvovaginal Atrophy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: InMode MD Ltd. · Industry
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Prospective, one arm, baseline-controlled At least 30 healthy adult female volunteers, from 2 investigational sites seeking treatment for Symptoms of Vulvovaginal Atrophy Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol The subject will return for 3 follow up visits: 3 months follow up (3M FU), 6 months follow up (6M FU), 12months follow up (12M FU) after the treatment. Total expected study duration is approximately 12 months.

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DEVICE	MorpheusV Applicator	Eligible subjects will receive 3 treatments 4 weeks apart with the MorpheusV Applicator according to the study protocol

Timeline

• Start date: 2021-08-10
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2022-05-31
• Last updated: 2024-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study