Clinical trial · Interventional
Feasibility and Added Value of the TRACMOTION Device for ESD
NCT06468800CI-TRIAL-00080282TRACMOTIONunknownN/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)
A single center non-randomized prospective clinical study, to evaluate the feasibility and added value of the CE-certified Tracmotion device in patients scheduled consecutively for ESD in the upper and lower gastrointestinal tract. After ESD, the endoscopists' opinion will be evaluated with a short questionnaire on experience with the Tracmotion device. The pathology report will be checked for radicality and microscopic damage of the removed lesion.
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 |
|---|---|---|---|
| Oesophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRACMOTION | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ESD with TRACMOTION
- description
- Patients already scheduled for ESD will undergo an ESD procedure with the aid of the TRACMOTION device.
- interventionNames
- Device: TRACMOTION
Primary outcomes (4)
- measure
- Procedure time
- timeFrame
- During endoscopic submucosal dissection procedure
- description
- Procedure time of the endoscopic submucosal dissection will be measured from start incision to end incision (in minutes)
- measure
- Dissection speed
- timeFrame
- During endoscopic submucosal dissection procedure
- description
- Dissection speed of ESD will be measured from start incision to end incision (square millimeter of dissected tissue per minute)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients scheduled for endoscopic submucosal dissection (upper and lower gastrointestinal tract); * Lesion is accessible with a therapeutic endoscope; * Written informed consent; * Age ≥18 years. Exclusion Criteria: * Coagulopathy (not corrected prior to endoscopic submucosal dissection); * Participating in a different experimental drug/device trial in the previous 3 months.
References
Publications (0)
Data not yet available
No reference posted for this study.