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An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

NCT03876860 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2023-10-05

No results posted yet for this study

Summary

This is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. The intervention is an enhanced vaginal dilator model, including a silicone band placed at the desired depth of dilator insertion. The new model will be compared against the traditional vaginal dilator model used as our institutional standard of care. We hypothesize the enhanced model will improve adherence, correct use and efficacy of vaginal dilator use.

Conditions

Interventions

DEVICE

Silicone Dilator

Addition of silicone band to standard vaginal dilator

DEVICE

Standard Dilator

Standard vaginal dilator

Sponsors & Collaborators

  • Margaret Liotta

    lead OTHER

Principal Investigators

  • Margaret R Liotta, DO · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-24
Primary Completion
2024-04-01
Completion
2024-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876860 on ClinicalTrials.gov