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
1 other identifier
interventional
147
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2012
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
October 29, 2018
CompletedDecember 11, 2018
November 1, 2018
1.4 years
March 19, 2012
July 28, 2017
November 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Safety of the PINPOINT System
Through hospital discharge or at 30 days post procedure, whichever is later
Study Arms (1)
Subjects Imaged with PINPOINT
EXPERIMENTALColonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Southern California
Los Angeles, California, 90089, United States
University of California, Irvine
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alicia Wilton
- Organization
- Novadaq Technologies, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Stamos, MD
University of California, Irvine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 22, 2012
Study Start
May 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
December 11, 2018
Results First Posted
October 29, 2018
Record last verified: 2018-11