Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

Radiation Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667859
• Other study ID #: 0398-18-RMB
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 31, 2020
• Est. primary completion date: July 31, 2020
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Radiation Injuries

Intervention

Diagnostic Test:
• Vaginal Tactile Imaging
Vaginal elasticity measurements using the Vaginal Tactile Imaging system.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal elasticity assessment	Vaginal elasticity as measured by the vaginal tactile imager.	up to 6 months from enrollment