Clinical trial · Interventional
Vagina-View Safety and Imaging Feasibility
Vagina-View: Safety & Imaging Feasibility Compared to Standard of Care Magnetic Resonance Imaging for Treating Vaginal Cancer Using Brachytherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
This prospective, single-arm feasibility study evaluates the use of the Vagina-View (VV) device to guide the placement of a multichannel applicator (MCA) during vaginal brachytherapy. The study aims to determine whether the device can accurately visualize vaginal mucosal tumor involvement and improve the precision of MCA placement. By reducing the need for MRI guidance, the VV device may offer a less resource-intensive approach while minimizing radiation exposure to healthy vaginal tissue and potentially reducing treatment-related side effects. VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV. The primary objective is to demonstrate the feasibility and positional accuracy of using the VV device for MCA placement.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vagina-View (VV) device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vagina-View (VV) device
- interventionNames
- Device: Vagina-View (VV) device
Primary outcomes (1)
- measure
- Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System
- timeFrame
- 1 month
- description
- Vaginal mucosal disease sites visualized with the Vagina-View (VV) device while in situ will be recorded and reported. Disease location will be documented using the VV grid coordinate system.
Secondary outcomes (4)
- measure
- Treatment device positioning versus MRI visualization
- timeFrame
- 1 month
- description
- Delineation of mucosal disease visible on endoscopic imaging or in relation to the VV grid coordinates + Delineation of disease visible on MRI. Measured in mm
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with gynecological cancer who is planned to receive MRI-guided intravaginal brachytherapy with an MCA applicator. * Able to receive and understand verbal and written information regarding study and able to give written informed consent Exclusion Criteria: * Patient receiving brachytherapy with a different brachytherapy device. * Patient with contraindications to MRI.
References
Publications (0)
Data not yet available