A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic Operations

NCT ID: NCT02070068

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-11-30

Brief Summary

Operations on the liver, bile ducts, and gallbladders are some of the most commonly performed abdominal operations in the United States. Cholecystectomy, removal of the gallbladder, is the most common of these with more than 750,000 performed annually. Injury to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1% to 0.5%), but it is an important source of patient morbidity. Serious injuries often require at least one surgical repair, and these repairs have variable long-term outcomes. Techniques to allow the visualization of the bile ducts may prevent such an injury, by providing vital information about the presence of gallstones in the CBD and show a surgical road map of the ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography of not exposing patients and healthcare providers to radiation. This technique also allows the superimposition of the cholangiogram onto the normal image.

This study is being conducted to optimize an imaging technique called PINPOINT. Images will be obtained during clinically necessary operations. The images will be evaluated to determine the best method for locating and outlining the anatomy. The information learned will guide the future use of PINPOINT in laparoscopic procedures.

Conditions

Biliary Anatomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group 1

ICG administered 10 minutes prior to time of visualization

Group Type: EXPERIMENTAL

PINPOINT System

Intervention Type: DEVICE

Group 2

ICG administered 45 min prior to time of visualization

Group Type: EXPERIMENTAL

PINPOINT System

Intervention Type: DEVICE

Interventions

PINPOINT System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

To be eligible for the study, subjects must fulfill all of the following criteria:

1. Subjects who are healthy men or women 18 years of age or older.

2. Subjects who are scheduled for laparoscopic biliary or hepatic operations.

3. Subjects who sign an approved informed consent form for the study.

4. Subjects who are willing to comply with the protocol.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the study:

1. Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine dyes.

2. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results.

3. Subjects who are pregnant or lactating females.

4. Subjects, who are actively participating in another investigational clinical study and who, in the Investigator's or Sponsor's opinion, should not be enrolled in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novadaq Technologies ULC, now a part of Stryker

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Ali Zarrinpar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

PP LBH 01

Identifier Type: -

Identifier Source: org_study_id