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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

March 19, 2012
June 30, 2014
May 2012
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01560377 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Perfusion Assessment in Laparoscopic Left Anterior Resection
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

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).

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Rectal Cancer
  • Colon Cancer
  • Crohn's Disease
  • Polyp
  • Procidentia
  • Diverticulitis
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
Experimental: Subjects Imaged with PINPOINT
Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
Intervention: Device: PINPOINT Endoscopic Fluorescence Imaging System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
November 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01560377
Version 1
No
Novadaq Technologies Inc.
Novadaq Technologies Inc.
Not Provided
Principal Investigator: Michael J Stamos, MD University of California, Irvine
Novadaq Technologies Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP