Clinical trial · Interventional
Feasibility Study of Navigated Endoscopy for the Placement of High Dose Rate Brachytherapy Applicators in the Esophagus and Lung
NCT03051802CI-TRIAL-00033079terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow recruitment
Summary
Brief summary (as posted)
The scope of this clinical trial is to assess the clinical feasibility of this procedure, optimize the protocol and perform an initial comparison of the positional accuracy of navigated endoscopy and applicator insertion versus the standard of care 2D fluoroscopy protocol.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophagus Cancer | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Navigated Endoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- proportion of navigated endoscopy procedures that were successfully completed
- timeFrame
- 18 months
- description
- To assess clinical feasibility of inserting intraluminal (esophagus or lung) HDR applicators using navigation technologies for tracking endoscope and applicator insertion. This study is designed to assess the workflow when using the EM tracking technology and the accuracy of the procedure will be measured by comparison with current standard of care.
- measure
- Positional accuracy
- timeFrame
- day 1
- description
- To compare the positional accuracy of the navigation procedure versus the current standard of care using 2D fluoroscopy using analysis of tracking data. All tracking data will be recorded for post-procedure analysis and comparison with the fluoroscopic imaging performed during current standard of care
- measure
- Optimize the clinical protocol using this technology
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Primary or metastatic cancer including endoluminal disease of either the lung or the esophagus * Intention to treat using high dose rate brachytherapy as part of standard radiotherapy. * Ability to provide written informed consent to participate in the study Exclusion Criteria: * Contraindications to standard radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness * Concurrent illness or condition that precludes subject from undergoing endoscopy * Patient is unable to tolerate an hour and a half long procedure. Standard of care practice is no more than 1 hour. However, with the additional tracking component, the procedure could be at most 1.5 hours long.
References
Publications (0)
Data not yet available
No reference posted for this study.