CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Injection of indocyanine green (ICG) +1 moredrug
Likely dose
Injection of indocyanine green (ICG) 2.5 mgfrom 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/NCT02070640
NCT02070640N/ACompleted
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Near Infrared Fluorescence Cholangiography During Cholecystectomy

Ohio State University·interventional·Posted Feb 25, 2014·Updated Oct 21, 2015

In Brief

A clinical study evaluating Injection of indocyanine green (ICG) and Near Infrared Cholangiography Fluorescence (NIRF-C) for Cholecystitis. Completed, enrolled 99 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate an imaging system using Indocyanine Green (ICG) to assist in real-time identification of anatomy during cholecystectomy (gallbladder removal). We propose to define the effectiveness of NIRF-C in identifying the cystic duct junction during cholecystectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholecystitis
CountriesUnited States
CollaboratorsStryker Instruments, Society of American Gastrointestinal and Endoscopic Surgeons

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2014
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.4 years ago

Interventions

Injection of indocyanine green (ICG)drug

2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.

Near Infrared Cholangiography Fluorescence (NIRF-C)device

These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.