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Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation

NCT04807387 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-08-06

Study results available
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Summary

Each year, females need surgery to create a vaginal canal or pelvic radiation to treat cancer. The result is often a narrowing or scarring of their vagina. To aid in healing a stent is often placed. However, current stents are poorly designed. The goal of this trial is to test newly designed vaginal stents, with the hope of replacing the poorly retained and uncomfortable standard of care. This trial has two aims. In the first aim, healthy participants will evaluate two newly designed vaginal stents for retention, comfort, and safety over 24 hours. The preferred stent will then be worn by the healthy participants for 2 weeks, again evaluating retention, comfort, and safety. In the second aim, the stents will be evaluated by two different patient populations. Adolescent participants undergoing vaginal surgery for genetic anomalies, will have a stent placed following surgery for continuous wear for 2 weeks. Adult participants undergoing vaginal brachytherapy will have the stent placed following the final brachytherapy treatment. These participants will wear the stent continuously for 2 weeks, followed by an additional 2 weeks of continuous wear. Each participant will evaluate the stent for retention, comfort, and safety. We hypothesize the newly designed stents will be retained longer and be more comfortable compared to current standards of care.

Conditions

  • Vaginal Stricture

Interventions

DEVICE

Vaginal Stent A

Ring stent

DEVICE

Vaginal Stent B

Flower stent

DEVICE

Vaginal Stent

Vaginal stent chosen from A or B that is the most comfortable

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • BioTex, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Julie CE Hakim, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2023-01-18
Completion
2023-01-18
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 NCT04807387 on ClinicalTrials.gov