Clinical trial · Interventional
Perfusion Assessment in Laparoscopic Left Anterior Resection
Open Label Clinical Study to Demonstrate the Utility of Intra-operative Perfusion Assessment Using NIR Fluorescence Angiography With the PINPOINT® Endoscopic Fluorescence Imaging System and to Assess the Impact of PINPOINT on the Surgical Decision Making Process and on Surgical Outcomes in Laparoscopic Left Anterior Resection Procedures
- 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 purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Crohn's Disease | — | UNRESOLVED | — |
| Diverticulitis | — | UNRESOLVED | — |
| Polyp | — | UNRESOLVED | — |
| Procidentia | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PINPOINT Endoscopic Fluorescence Imaging System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Subjects Imaged with PINPOINT
- description
- Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
- interventionNames
- Device: PINPOINT Endoscopic Fluorescence Imaging System
Primary outcomes (1)
- measure
- PINPOINT System Utility in Left Colectomy Surgery
- timeFrame
- Day of Operation - Day 1
- description
- To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
Secondary outcomes (1)
- measure
- Safety of the PINPOINT System
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge) * A negative pregnancy test for women of childbearing potential prior to surgery Exclusion Criteria: * Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes * Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure * Subject is a pregnant or lactating female
References
Publications (0)
Data not yet available