Clinical trial · Interventional
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections: Observational First-in-human Pilot Safety Trial -TRIDENT-
NCT05973227CI-TRIAL-00078995TRIDENTcompletedN/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)
The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.
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 |
|---|---|---|---|
| Left-sided Colorectal Resection : Colonic Neoplasms | — | UNRESOLVED | — |
| Left-sided Colorectal Resection : Diverticular Diseases | — | UNRESOLVED | — |
| Left-sided Colorectal Resection : Rectal Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| use of the TRIDENT system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- interventional arm (use of TRIDENT system)
- interventionNames
- Device: use of the TRIDENT system
Primary outcomes (1)
- measure
- image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.
- timeFrame
- 30 days FU
- description
- descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition.
Secondary outcomes (1)
- measure
- - level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of: * Colon cancer OR * Sigmoid diverticular disease OR * Rectal cancer * All genders * Age \> 18 years old * Ability to understand the information related to the study protocol Exclusion Criteria: * Pregnancy or breastfeeding * Contraindications to anaesthesia * Inability to provide a written informed consent * Inclusion in a different ongoing clinical trial * Emergency procedure * Abdomino-perineal resection * Hartmann procedure * Patient is part of vulnerable population (e.g., prisoners, mentally disabled)
References
Publications (0)
Data not yet available
No reference posted for this study.