CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Indocyanine Green +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01424293
NCT01424293N/ACompleted

The Use of Fluorescent Imaging to Evaluate Bowel Anastomotic Perfusion

Maimonides Medical Center·interventional·Posted Aug 26, 2011·Updated Jul 13, 2021

In Brief

A clinical study evaluating Indocyanine Green and The SPY® Intraoperative Imaging System for Rectal Neoplasms and 2 related conditions. Completed, enrolled 7 participants across 1 site.

Detailed Summary

Bowel removal is indicated for various types of colon and rectal disease, including colon cancer, rectal cancer, diverticulitis, and inflammatory bowel disease among others. Following removal of the diseased segment of bowel your surgeon will reconnect the two healthy ends to reconstruct a continuous bowel tube. If the bowel leaks it can become an extremely dangerous situation. The cause of leakage has many causes and is not well understood, but appears to be at least in part due to not having enough blood going to the bowel. There is currently no way to evaluate the blood supply to the bowel. The purpose of this study is to utilize a special camera to evaluate the blood supply of the bowel. This new system is called the Spy-scope. This system may assist surgeons in reducing the occurrence of leaks

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2011
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.8 years ago

Interventions

Indocyanine Greendevice

1ml of intravenous ICG and imaging transanally using the Spyscope system

The SPY® Intraoperative Imaging Systemdevice