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

NCT02070068 | Completed Early Phase 1

• 1 other identifier: PP LBH 01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  10 minutes after injection

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

  45 minutes after injection

Study Arms (2)

Group 1

EXPERIMENTAL

ICG administered 10 minutes prior to time of visualization

Device: PINPOINT System

Group 2

EXPERIMENTAL

ICG administered 45 min prior to time of visualization

Device: PINPOINT System

Interventions

PINPOINT System DEVICE

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Novadaq Technologies ULC, now a part of Stryker: collaborator

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 24, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)