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Clinical Trial Summary

Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements. In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.


Clinical Trial Description

This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis. The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05002751
Study type Observational
Source University of California, San Diego
Contact Sandi Matranga, MHA
Phone 619-838-9003
Email smatranga@health.ucsd.edu
Status Recruiting
Phase
Start date October 6, 2022
Completion date February 28, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Terminated NCT04807387 - Newly Designed Vaginal Stent to Improve Patient Comfort and Healing Following Vaginal Surgery or Vaginal Radiation N/A