Perfusion Assessment in Laparoscopic Left Anterior Resection (PILLAR II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01560377
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):
Novadaq Technologies Inc.

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Colon Cancer Crohn's Disease Polyp Procidentia Diverticulitis Device: PINPOINT Endoscopic Fluorescence Imaging System Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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 Start Date : May 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Subjects Imaged with PINPOINT
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

Primary Outcome Measures :
  1. Incidence of use of PINPOINT System to aid in surgical colectomies decision making. [ Time Frame: Day of procedure - Day 1 ]
    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.

Secondary Outcome Measures :
  1. Incidence of all other operative complications [ 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01560377

United States, California
University of Southern California
Los Angeles, California, United States, 90089
University of California, Irvine
Orange, California, United States, 92868
University of California San Diego
San Diego, California, United States, 92093
University of California San Francisco
San Francisco, California, United States, 94115
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Louisiana
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Beth Israel Medical Center
New York, New York, United States, 10003
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Novadaq Technologies Inc.
Principal Investigator: Michael J Stamos, MD University of California, Irvine

Responsible Party: Novadaq Technologies Inc. Identifier: NCT01560377     History of Changes
Other Study ID Numbers: Version 1
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by Novadaq Technologies Inc.:
Laparoscopic low anterior colon resection
Laparoscopic left colectomy
Rectal cancer
Colon cancer
Crohn's Disease

Additional relevant MeSH terms:
Rectal Neoplasms
Colonic Neoplasms
Crohn Disease
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Inflammatory Bowel Diseases
Intraabdominal Infections
Pathological Conditions, Anatomical