Radiation InjuriesNCT03667859
Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation
An observational study of Radiation Injuries, run by Rambam Health Care Campus at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Radiation Injuries
- What is being tested?
- Vaginal Tactile Imaging
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2018to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Adult, Older adult
Study population: Women undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.
Who may be able to join
- Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.
Who cannot join
- Women that are not in the age range.
- Women with massive vaginal bleeding.
- Women after pelvic exenteration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging
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.
- Conditions
- Radiation Injuries
- Being tested
- Vaginal Tactile Imaging
- Medical subject headings
- Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Tactile ImagingDiagnostic test
Vaginal elasticity measurements using the Vaginal Tactile Imaging system.
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing Brachytherapy | Women with either uterine or cervical malignancy treated primarily by brachytherapy. Receives: Diagnostic Test: Vaginal Tactile Imaging | |
| Women undergoing Pelvic Radiation | Women with either uterine or cervical malignancy treated primarily by pelvic radiation. Receives: Diagnostic Test: Vaginal Tactile Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal elasticity assessment
Vaginal elasticity as measured by the vaginal tactile imager.
Measured: up to 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Nov 2018
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667859
- Sponsor's protocol ID
- 0398-18-RMB
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging
- ClinicalTrials.gov ID
- NCT03667859
- Acronym / sponsor ID
- 0398-18-RMB
- Conditions
- Radiation Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women undergoing Brachytherapy | – | Diagnostic Test: Vaginal Tactile ImagingWomen with either uterine or cervical malignancy treated primarily by brachytherapy. |
| Women undergoing Pelvic Radiation | – | Diagnostic Test: Vaginal Tactile ImagingWomen with either uterine or cervical malignancy treated primarily by pelvic radiation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.
Key inclusion criteria (1 listed)
- Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.
Key exclusion criteria (3 listed)
- Women that are not in the age range.
- Women with massive vaginal bleeding.
- Women after pelvic exenteration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Tactile ImagingVaginal elasticity measurements using the Vaginal Tactile Imaging system. | Diagnostic test | Women undergoing Brachytherapy, Women undergoing Pelvic Radiation |
Primary outcome
Vaginal elasticity assessment
Time frame: up to 6 months from enrollment
Vaginal elasticity as measured by the vaginal tactile imager.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Injuries, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal elasticity assessment (time frame: up to 6 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.