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OpenTrials
Completed

NCT Number: NCT03667859

Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.

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Key information

Conditions

Radiation Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal Tactile Imaging

Diagnostic Test

Vaginal elasticity measurements using the Vaginal Tactile Imaging system.

Primary outcomes

  1. Vaginal elasticity assessment

    Time frame: up to 6 months from enrollment

    Vaginal elasticity as measured by the vaginal tactile imager.

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 12, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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