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NCT04807387 · ClinicalTrials.gov registry record · NA
Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 6
- Enrollment target
NCT04807387 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 6 participants.
The verdict
NCT04807387, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 6 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Vaginal Stent A
- DEVICE Vaginal Stent B
- DEVICE Vaginal Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-05-05 |
| Est. Completion | 2023-01-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04807387
The ClinicalTrials.gov registry entry for NCT04807387 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Vaginal Stent A is the first listed.
NCT04807387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04807387 about?
NCT04807387 is a clinical study titled "Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation". 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...
What is the current status of trial NCT04807387?
This trial is currently terminated. It is a NA study. The enrollment target is 6 participants. The study started on 2022-05-05. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT04807387?
The interventions under investigation include: Vaginal Stent A (DEVICE), Vaginal Stent B (DEVICE), Vaginal Stent (DEVICE).
Who is sponsoring clinical trial NCT04807387?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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