Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-30 @ 10:05 AM
Study NCT ID:
NCT05002751
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantifying Radiation Induced Vaginal Stenosis
Sponsor:
University of California, San Diego
Organization:
Study Overview
Official Title:
Quantifying Radiation Induced Vaginal Stenosis for the Development of a Novel Dilator Device
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QRIVS
Brief 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.
In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.
Detailed 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.
The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: