A Phase 1 interventional study of PINPOINT Endoscopic Fluorescence Imaging System in Rectal Cancer, Colon Cancer and Crohn's Disease, sponsored by Novadaq Technologies ULC, now a part of Stryker. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-11.
Sponsored by Novadaq Technologies ULC, now a part of Stryker · Phase 1, Interventional, and Supportive care
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.
Colectomy is a surgical procedure in which a part or all of the colon is removed. It is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted bowel.
This study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by NIR fluorescence angiography in colectomy. The initial phase (Phase I) consisted of a number of small investigative studies that have now been completed. Upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (Phase III). Information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 147 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Novadaq Technologies ULC, now a part of Stryker is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
Device: PINPOINT Endoscopic Fluorescence Imaging System
The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
PINPOINT System Utility in Left Colectomy Surgery
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.
Time frame: Day of Operation - Day 1
Safety of the PINPOINT System
To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.
Time frame: Through hospital discharge or at 30 days post procedure, whichever is later
A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Patients were enrolled at 11 centers in the United States.
| Milestone | Subjects Imaged With PINPOINT |
|---|---|
| Started | 147 |
| Eligible for analysis | 139 |
| Completed | 147 |
| Not completed | 0 |
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.
| Participants | Subjects Imaged With PINPOINT |
|---|---|
| Change to surgical plan due to Fluorescence | 11 |
| No change to surgical plan due to Fluorescence | 128 |
To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.
| Participants | Subjects Imaged With PINPOINT |
|---|---|
| Clinical anastomotic leak & confirmed by radiology | 2 |
| Post-operative fever | 7 |
| Delay in return of bowel function | 5 |
| No major post-operative clinical complication | 125 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects Imaged With PINPOINT | — | 23/139 (16.5%) | 0/139 (0%) |
| Event | Subjects Imaged With PINPOINT |
|---|---|
| Anastomotic leakSurgical and medical procedures | 2/139 |
| Pelvic abscessInfections and infestations | 2/139 |
| C. difficile colitisInfections and infestations | 2/139 |
| VomitingGastrointestinal disorders | 2/139 |
| Abdominal wall infectionInfections and infestations | 1/139 |
| Acute renal failureRenal and urinary disorders | 1/139 |
| Blood transfusionBlood and lymphatic system disorders | 1/139 |
| FeverGeneral disorders | 1/139 |
| IleusGastrointestinal disorders | 1/139 |
| Ileus requiring nasogastric tubeGastrointestinal disorders | 1/139 |
Patients undergoing left colectomy/low anterior resection
| Age, Continuous(years) | Subjects Imaged With PINPOINT |
|---|---|
| Mean | 58 (44 to 72) |
| Sex: Female, Male(Participants) | Subjects Imaged With PINPOINT |
|---|---|
| Female | 65 |
| Male | 74 |
| Ethnicity (NIH/OMB)(Participants) | Subjects Imaged With PINPOINT |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 129 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Subjects Imaged With PINPOINT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 14 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 106 |
| More than one race | 0 |
| Unknown or Not Reported | 12 |
| Region of Enrollment(participants) | Subjects Imaged With PINPOINT |
|---|---|
| United States | 139 |
| ASA Classification (American Society of Anesthesiologists)(Participants) | Subjects Imaged With PINPOINT |
|---|---|
| I (normal healthy patient) | 17 |
| II (patient with mild systemic disease) | 73 |
| III (patient with severe systemic disease) | 46 |
| IV (severe life threating systemic disease) | 3 |
| BMI(Participants) | Subjects Imaged With PINPOINT |
|---|---|
| BMI > 30 kg/m^2 | 42 |
| BMI < 30 kg/m^2 | 97 |
| Preoperative chemotherapy(Participants) | Subjects Imaged With PINPOINT |
|---|---|
| Yes | 13 |
| No | 126 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Novadaq Technologies ULC, now a part of Stryker