Phase 1
Completed N=147
Perfusion Assessment in Laparoscopic Left Anterior Resection
Colorectal Cancer · Crohn's Disease · Polyp · Procidentia
Source: ClinicalTrials.gov NCT01560377 ↗
Enrolled (actual)
147
Serious AEs
16.6%
Results posted
Oct 2018
Primary outcomePrimary: PINPOINT System Utility in Left Colectomy Surgery — 11; 128 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PINPOINT System Utility in Left Colectomy Surgery |
11; 128 | — |
| SECONDARY Safety of the PINPOINT System |
2; 7; 5; 125 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01560377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.