NCT03667859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

September 10, 2018

Last Update Submit

September 12, 2020

Conditions

Radiation Injuries

Outcome Measures

Primary Outcomes (1)

  • Vaginal elasticity assessment

    Vaginal elasticity as measured by the vaginal tactile imager.

    up to 6 months from enrollment

Study Arms (2)

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

Vaginal Tactile ImagingDIAGNOSTIC_TEST

Vaginal elasticity measurements using the Vaginal Tactile Imaging system.

Women undergoing BrachytherapyWomen undergoing Pelvic Radiation

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with gynecological malignancies.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Roy Lauterbach, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 12, 2018

Study Start

November 1, 2018

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

IL(1)