- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560377
Perfusion Assessment in Laparoscopic Left Anterior Resection (PILLAR II)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90089
- University of Southern California
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Orange, California, United States, 92868
- University of California, Irvine
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San Diego, California, United States, 92093
- University of California San Diego
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San Francisco, California, United States, 94115
- University of California San Francisco
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Florida
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Weston, Florida, United States, 33331
- Cleveland Clinic Florida
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New York
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Brooklyn, New York, United States, 11219
- Maimonides Medical Center
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New York, New York, United States, 10003
- Beth Israel Medical Center
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New York, New York, United States, 10021
- Weill Cornell Medical College
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospital Case Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Subjects Imaged with PINPOINT
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PINPOINT System Utility in Left Colectomy Surgery
Time Frame: Day of Operation - Day 1
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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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of the PINPOINT System
Time Frame: Through hospital discharge or at 30 days post procedure, whichever is later
|
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.
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Through hospital discharge or at 30 days post procedure, whichever is later
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Inflammatory Bowel Diseases
- Diverticular Diseases
- Prolapse
- Rectal Neoplasms
- Crohn Disease
- Diverticulitis
- Colonic Neoplasms
Other Study ID Numbers
- Version 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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