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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01560377
Other study ID # Version 1
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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