NCT03667859CompletedNot Applicable
Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging
Rambam Health Care Campus1 site in 1 country25 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Vaginal elasticity assessment
Study Overview
Brief Summary
Female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.
Detailed Description
Patients will be recruited and sign a consent form. The patients included are patients with either uterine/cervical malignancies. Each participant undergoes radiation treatment either as primary or complementary treatment.
Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:
- Before the first treatment session (baseline).
- After the last session of laser treatment.
- 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.
Exclusion Criteria
- •Women that are not in the age range.
- •Women with massive vaginal bleeding.
- •Women after pelvic exenteration.
Outcomes
Primary Outcomes
Vaginal elasticity assessment
Time Frame: up to 6 months from enrollment
Vaginal elasticity as measured by the vaginal tactile imager.
Secondary Outcomes
No secondary outcomes reported
Investigators
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus
Study Sites (1)
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