Completed

NCT Number: NCT02070068

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

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.

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Key information

Conditions

Biliary Anatomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Subjects who are healthy men or women 18 years of age or older.
Subjects who are scheduled for laparoscopic biliary or hepatic operations.
Subjects who sign an approved informed consent form for the study.
Subjects who are willing to comply with the protocol.

Exclusion criteria

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

Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine dyes.
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.
Subjects who are pregnant or lactating females.
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.

Treatment and study plan

PINPOINT System

Device

Primary outcomes

Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)

Time frame: 10 minutes after injection
Ease of Identification of Biliary Anatomy as Scored by the Surgeon (1-5 scale)

Time frame: 45 minutes after injection

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

Novadaq Technologies ULC, now a part of Stryker

Registry information

Official study title

A Pilot Study to Optimize Imaging When Utilizing the PINPOINT Endoscopic Fluorescence Imaging System for Identification of Biliary Anatomy During Laparoscopic Biliary and Hepatic Operations

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 24, 2014
Registry last updated: Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.