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A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes

NCT03547089 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-15

No results posted yet for this study

Summary

The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.

Conditions

  • Vaginal Atrophy
  • Genitourinary System; Disorder, Female
  • Vaginal Abnormality
  • Sexual Dysfunction
  • Sexual Problem

Interventions

DEVICE

Viveve®

A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2

Sponsors & Collaborators

  • W. Grant Stevens, MD

    lead OTHER

Principal Investigators

  • W G Stevens, MD · Marina Plastic Surgery

  • Ali A Qureshi, MD · Marina Plastic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-03-01
Completion
2020-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03547089 on ClinicalTrials.gov