Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation
Public ClinicalTrials.gov record NCT04807387. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Newly-designed Vaginal Stent to Improve Tissue Healing for Girls and Women With Congenital and Reproductive Anomalies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04807387
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 6 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years to 64 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 4, 2022
- Primary completion
- Jan 17, 2023
- Completion
- Jan 17, 2023
- Last update posted
- Aug 5, 2024
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04807387, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04807387 live on ClinicalTrials.gov.