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A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

NCT02205307 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2020-06-24

Study results available
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Summary

This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

Conditions

Interventions

DEVICE

PINPOINT

DEVICE

SPY Elite

Sponsors & Collaborators

  • Novadaq Technologies ULC, now a part of Stryker

    lead INDUSTRY

Principal Investigators

  • Michael J Stamos, MD · University of California, Irvine

  • Steven Wexner, MD · Cleveland Clinic Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205307 on ClinicalTrials.gov