Cholecystitis Clinical Trial
— NIRF-COfficial title:
Near Infrared Fluorescence Cholangiography During Cholecystectomy
Verified date | September 2015 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Age 18-89 - Planned laparoscopic cholecystectomy Exclusion Criteria: - Inability to provide informed consent - Pregnant - Allergy to ICG, iodine, and/or shellfish - Acute cholecystitis, cholangitis, and/or cirrhosis (main study) - Lactating |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | Society of American Gastrointestinal and Endoscopic Surgeons, Stryker Instruments |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complications Related to ICG | A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit. | From time of injection to 1st post-op follow-up | Yes |
Secondary | Incidence of Anatomic Identification With NIRF-C | Incidence of anatomic identification with NIRF-C and intraoperative cholangiography. | Intraoperative | No |
Secondary | Time to Complete NIRF-C and IOC | The time required to complete NIRF-C and intraoperative cholangiography will be analyzed. | Intraoperative | No |
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