Perfusion Assessment in Laparoscopic Left Anterior Resection (NCT01560377) | Clinical Trial Compass
CompletedPhase 1
Perfusion Assessment in Laparoscopic Left Anterior Resection
United States147 participantsStarted 2012-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used something called the PINPOINT System to assess blood flow during laparoscopic left colon surgery — can you explain what that technology does and whether it's now part of how you perform this type of operation?
2Since this was a Phase 1 trial focused on testing whether the PINPOINT imaging system was useful rather than proving it improved patient outcomes, what do we actually know so far about whether it reduces complications like leaks at the surgical connection point?
3My condition is listed among those studied in this trial — given that the trial is now completed, has the data from it changed the way surgeons here approach left colectomy for patients like me?
4Are there any follow-up or Phase 2 trials building on this PINPOINT research that might be worth looking into, or is this imaging approach already standard of care at your hospital?
5Compared to a conventional laparoscopic left colectomy without this perfusion assessment technology, what are the potential benefits and risks I should weigh when deciding on my surgical approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PINPOINT System Utility in Left Colectomy Surgery
Timeframe: Day of Operation - Day 1
Trial details
NCT IDNCT01560377
SponsorNovadaq Technologies ULC, now a part of Stryker