Clinical trial · Interventional
Investigation to Evaluate Safety and Efficacy of the Endodrill Model X Biopsy Instrument
Safety and Efficacy of the Endodrill Model X Biopsy Instrument When Sampling Tumours in the Upper Gastrointestinal Tract
NCT04519138CI-TRIAL-00055327completedN/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 is an investigator led prospective open label investigation, performed at three clinics in Sweden, comparing the flexible endoscopic biopsy instrument Endodrill Model X with the standard sampling method endoscopic ultrasound fine needle aspiration/biopsy. Assessment of safety is the primary objective and performance is the secondary objective.
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 |
|---|---|---|---|
| Tumor Sampling | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endodrill Model X | Device | — | UNRESOLVED |
| Fine-needle aspiration/biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Endodrill Model X
- description
- Three consecutive samples will be taken using the Endodrill Model X instrument.
- interventionNames
- Device: Endodrill Model X
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic ultrasound guided fine-needle aspiration/biopsy
- description
- Three consecutive samples will be taken using the the standard method fine-needle aspiration/biopsy.
- interventionNames
- Device: Fine-needle aspiration/biopsy
Primary outcomes (1)
- measure
- Proportion of patients with pre-specified adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults at least 18 years of age at the day of inclusion * Signed informed consent * Submucosal tumor of the upper gastrointestinal tract with tumor size ≥ 10 mm, well localized by the endoscopic examination Exclusion Criteria: * Suspicion of vascular tumor (e.g. pulsating tumor) * Ongoing treatment with anticoagulants (e.g. Warfarin) * Ongoing treatment with immunosuppressive drugs * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.