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Flourish HEC to Prevent Recurrence of BV

NCT05386147 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-03-08

No results posted yet for this study

Summary

In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.

Conditions

  • Bacterial Vaginosis

Interventions

DEVICE

Flourish HEC Vaginal Care System (contains a class II medical device plus other unregulated components)

see arm description

Sponsors & Collaborators

  • Center for Pelvic Health

    collaborator OTHER

  • Vaginal Biome Science

    lead OTHER

Principal Investigators

  • Susan Kellogg-Spadt, PhD, CRNP · Center for Pelvic Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
52 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2022-11-15
Completion
2022-11-15
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 NCT05386147 on ClinicalTrials.gov