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Evaluation Using Intragen Fractional Radiofrequency With NeuViVa for the Treatment of Vaginal Laxity and Urogynecology Symptoms.

NCT03280446 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-03-23

No results posted yet for this study

Summary

This study will evaluate the clinical efficacy of a Transcutaneous Fractional Radiofrequency Device (TFRF) for the treatment of vaginal laxity (VL) and urogynecological symptoms.

Conditions

Interventions

DEVICE

Intragen fractional radiofrequency with NeuViVa

The Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe.

Sponsors & Collaborators

  • SHERRY Thomas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-23
Primary Completion
2018-08-31
Completion
2019-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03280446 on ClinicalTrials.gov