Status:
TERMINATED
Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
BioTex, Inc.
Conditions:
Vaginal Stricture
Eligibility:
FEMALE
13-64 years
Phase:
NA
Brief 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. H...
Detailed Description
After surgery or radiation to the vaginal area, a common patient risk is that their vaginal tissue sticks together and scars. This can cause the vaginal canal to narrow or shorten. This can occur in u...
Eligibility Criteria
Inclusion
- Inclusion Criteria (healthy participants):
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
- Understand English or Spanish to a 5th grade level
- No prior history of vaginal surgery or radiation
- Inclusion Criteria (pediatric participants):
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
- Understand English or Spanish to a 5th grade level
- Undergoing vaginal surgery
- Inclusion Criteria (adult radiation participants):
- Not pregnant
- participant consent or parent/guardian consent \& participant assent
- Understand requirements of study
- Agree to abide by study restrictions
- Able to travel to Houston
- Understand English or Spanish to a 5th grade level
- Undergoing vaginal brachytherapy
- Exclusion Criteria (all arms):
- Non-English or Spanish speaker
- Pregnant
- BMI \> 45
- Diabetic neuropathy limiting use of hands
- Other limited mobility of hands
- Vaginismus
- Urinary retention
- Vaginal bacterial infection
- Vaginal fungal infection
- Allergies to stent materials
- Seizure disorder
- Pain with sexual intercourse or tampon insertion
Exclusion
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04807387
Start Date
May 5 2022
End Date
January 18 2023
Last Update
August 6 2024
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030