Status:
COMPLETED
A Novel Tapered Applicator for Vaginal Vault Brachytherapy
Lead Sponsor:
Yale University
Conditions:
Endometrial Cancer
Brachytherapy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will assess the comfort and fit of a novel applicator for endometrial cancer patients who are candidates for vaginal brachytherapy. This study is only assessing the applicator fitting. No p...
Detailed Description
In the treatment of endometrial cancer, adjuvant vaginal brachytherapy is typically performed to deliver radiation dose to the apex of the vagina with a fixed diameter vaginal applicator which extends...
Eligibility Criteria
Inclusion
- Eligibility Criteria
- Patients with stage I-IV endometrial cancer.
- Patient must have been treated with hysterectomy.
- A radiation oncology determined the patient's disease warrants adjuvant treatment with vaginal brachytherapy as sole adjuvant radiotherapy.
- Patient consented to receive standard of care vaginal brachytherapy treatment.
- Vaginal cuff deemed healing appropriately by treating radiation oncologist during initial consultation without evidence of infection, pelvic symptoms, or other surgical complications.
- 18 ≤ Age
- English speaking.
- Exclusion Criteria
- Subjects meeting any of the criteria below may not participate in the study:
- Requires premedication with pain medications and/or anxiolytics during applicator fitting.
- Will receive pelvic EBRT.
- Prior known diagnosis of lupus, scleroderma, dermatomyositis, Crohn's disease, ulcerative colitis, pacemakers, or other contraindications to radiotherapy.
Exclusion
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04318340
Start Date
July 16 2020
End Date
March 20 2023
Last Update
July 14 2023
Active Locations (1)
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1
Smilow Cancer Hospital
New Haven, Connecticut, United States, 06519