Perfusion Assessment in Laparoscopic Left Anterior Resection

Rectal Cancer Clinical Trial

— PILLAR II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560377
• Other study ID #: Version 1
• Status: Completed
• Phase: Phase 1
• Start date: May 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2018
• Source: Novadaq Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Crohn Disease
• Crohn's Disease
• Diverticulitis
• Polyp
• Procidentia
• Prolapse
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York
United States	University Hospital Case Medical Center	Cleveland	Ohio
United States	University of Southern California	Los Angeles	California
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of California, Irvine	Orange	California
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novadaq Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of the PINPOINT System	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.	Through hospital discharge or at 30 days post procedure, whichever is later