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CompletedNCT03667859Updated Sep 16, 2020

Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation

An observational study in Radiation Injuries, sponsored by Rambam Health Care Campus. Completed at 1 site in Israel. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Rambam Health Care Campus · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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

Read the 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.
02

Conditions studied

  • Radiation Injuries

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03

In context

Radiation Injuries

108 studies on the registry are indexed under Radiation Injuries; 46 are open to participants now.

This study's enrollment of 25 is below the median of 105 across 41 observational studies indexed under Radiation Injuries.

Browse Radiation Injuries studies →

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Women undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.

Inclusion criteria

  • Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.

Exclusion criteria

Exclusion Criteria:

  • Women that are not in the age range.
  • Women with massive vaginal bleeding.
  • Women after pelvic exenteration.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Women undergoing Brachytherapy

    Women with either uterine or cervical malignancy treated primarily by brachytherapy.

    Diagnostic Test: Vaginal Tactile Imaging

  • Women undergoing Pelvic Radiation

    Women with either uterine or cervical malignancy treated primarily by pelvic radiation.

    Diagnostic Test: Vaginal Tactile Imaging

Interventions

  • Diagnostic testVaginal Tactile Imaging

    Vaginal elasticity measurements using the Vaginal Tactile Imaging system.

06

What researchers measure

Primary outcomes

  1. Vaginal elasticity assessment

    Vaginal elasticity as measured by the vaginal tactile imager.

    Time frame: up to 6 months from enrollment

07

Study locations

1 site
  • Rambam health care campus
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03667859
Lead sponsor
Rambam Health Care Campus
Responsible party
ROY LAUTERBACH MD (Principal Investigator, Rambam Health Care Campus) — Principal investigator
First posted
Sep 12, 2018
Start date
Nov 1, 2018
Primary completion
Jul 31, 2020
Completion
Aug 31, 2020
Last update
Sep 16, 2020

Study contacts

Roy Lauterbach, MD
principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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