Clinical trial · Interventional
A Novel Tapered Applicator for Vaginal Vault Brachytherapy
A Novel Tapered Applicator for Post-Hysterectomy Vaginal Vault Brachytherapy: Quality-of-Life Assessment of Patient Comfort and In Vivo Dosimetry
NCT04318340CI-TRIAL-00068015completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 patients in this study will be treated with the novel applicator.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brachytherapy | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard applicator | Other | — | UNRESOLVED |
| Tapered applicator | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Applicators
- description
- All patients will be fitted with the 2.6 cm applicator and sized up to the 3.0 cm applicator if tolerable.
- interventionNames
- Other: Standard applicator
- type
- EXPERIMENTAL
- label
- Tapered Applicator
- description
- All patients will be fitted with the novel tapered 3.0 cm applicator. Patients have the option of having magnetic resonance imaging with the tapered applicator in place.
- interventionNames
- Other: Tapered applicator
Primary outcomes (2)
- measure
- Patient comfort
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.