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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Imaged with PINPOINT | Experimental | Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PINPOINT Endoscopic Fluorescence Imaging System | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of Operation - Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through hospital discharge or at 30 days post procedure, whichever is later |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Stamos, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States | ||
| University of California, Irvine |
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A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Patients were enrolled at 11 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Imaged With PINPOINT | Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Orange |
| California |
| 92868 |
| United States |
| University of California San Diego | San Diego | California | 92093 | United States |
| University of California San Francisco | San Francisco | California | 94115 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| University Hospital Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Eligible for Analysis |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Patients undergoing left colectomy/low anterior resection
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Imaged With PINPOINT | Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| ASA Classification (American Society of Anesthesiologists) | Count of Participants | Participants |
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| BMI | Count of Participants | Participants |
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| Preoperative chemotherapy | Count of Participants | Participants |
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| Preoperative radiation therapy | Count of Participants | Participants |
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| Diagnosis | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Day of Operation - Day 1 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Through hospital discharge or at 30 days post procedure, whichever is later |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Imaged With PINPOINT | Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. 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 | 23 | 139 | 0 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic leak | Surgical and medical procedures |
| |||
| Pelvic abscess | Infections and infestations |
| |||
| Abdominal wall infection | Infections and infestations |
| |||
| Acute renal failure | Renal and urinary disorders |
| |||
| Blood transfusion | Blood and lymphatic system disorders |
| |||
| C. difficile colitis | Infections and infestations |
| |||
| Fever | General disorders |
| |||
| Ileus | Gastrointestinal disorders |
| |||
| Ileus requiring nasogastric tube | Gastrointestinal disorders |
| |||
| Small bowel obstruction | Gastrointestinal disorders |
| |||
| Incisional hernia | Gastrointestinal disorders |
| |||
| Thrombosed left renal artery | Vascular disorders |
| |||
| Urinary retention | Renal and urinary disorders |
| |||
| Urinary tract infection | Renal and urinary disorders |
| |||
| Wound infection | Infections and infestations |
| |||
| Hypertension | Cardiac disorders |
| |||
| Hypokalemia | Hepatobiliary disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alicia Wilton | Novadaq Technologies, Inc. | 1.905.629.3822 | 209 | awilton@novadaq.com |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D003424 | Crohn Disease |
| D011127 | Polyps |
| D011391 | Prolapse |
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003108 | Colonic Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000076385 | Diverticular Diseases |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
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| Unknown or Not Reported |
|
| III (patient with severe systemic disease) |
|
| IV (severe life threating systemic disease) |
|
| Colon cancer |
|
| Polyp |
|
| Procidentia |
|
| Crohn's disease |
|
| Colovesical fistula |
|
| Radiation stricture |
|
| Sigmoid volvulus |
|
|