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RF Rejuvenation for Pelvic Floor and Vagina

NCT03536819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-18

Study results available
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Summary

Evaluation of efficacy and safety of the Votiva RF system with the Forma V handpiece for vaginal treatments.

Conditions

  • Symptoms Associated With Pelvic Floor Weakness

Interventions

DEVICE

Votiva

The applicator uses radio-frequency energy to treat the vaginal canal

Sponsors & Collaborators

  • InMode MD Ltd.

    lead INDUSTRY

Principal Investigators

  • George Kouris, MD · Midwest Plastic Surgery, 5201 S. Willow Springs Road, Suite 440 LaGrange, IL, 60525

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-17
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03536819 on ClinicalTrials.gov