Perfusion Assessment in Laparoscopic Left Anterior Resection (PILLAR II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novadaq Technologies Inc.
ClinicalTrials.gov Identifier:
NCT01560377
First received: March 19, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novadaq Technologies Inc.:

Primary Outcome Measures:
  • Incidence of use of PINPOINT System to aid in surgical colectomies decision making. [ Time Frame: Day of procedure - Day 1 ] [ Designated as safety issue: No ]
    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:
  • Incidence of all other operative complications [ Time Frame: through hospital discharge or at 30 days post procedure, whichever is later ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 147
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560377

Locations
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
Weill Cornell Medical College
New York, New York, United States, 10021
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Ohio
University Hospital Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Novadaq Technologies Inc.
Investigators
Principal Investigator: Michael J Stamos, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Novadaq Technologies Inc.
ClinicalTrials.gov Identifier: NCT01560377     History of Changes
Other Study ID Numbers: Version 1
Study First Received: March 19, 2012
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Crohn Disease
Diverticulitis
Prolapse
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Infection
Inflammatory Bowel Diseases
Intestinal Diseases
Intraabdominal Infections
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 30, 2014