NCT05111808

Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue

A Non-Randomized, Prospective, Open Label, Single-site Feasibility Trial for Real-time Identification of the Ureters With a Methylene-blue fluoroPhore

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized prospective, open label, single site study to evaluate the feasibility of recruitment for the use of an Investigational Endoscopic Fluorescence Imaging System, PINPOINT, in intraoperative bilateral visualization of ureters using intravenous injection of methylene blue. Feasibility of urine sample collection during surgery will also be assessed.

Detailed description

Background - During certain abdominal surgeries there is difficulty in finding the ureters, which act as a conduit for urine from the kidneys to the bladder. If the ureters are sectioned during surgery this causes great suffering for the patient and increased costs for the hospital and the National Health Service. Even experienced surgeons are at risk of causing this dreaded complication. Methylene blue can emit a fluorescent signal and highlight the ureters in real time during surgical procedures. A study is necessary to evaluate the effectiveness of methylene blue fluorescence to identify the ureters during surgery. Methods - In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included. The feasibility of recruitment of these patients will be assessed using a screening log. Included patients with receive intraoperative methylene blue injection in increasing doses. Urine samples will be taken to establish the conversion of methylene blue to leucomethylene blue. Expected results - the investigators expect to define the recruitment rate of the patient group of interest and to identify the causes for non recruitment. Secondary outcomes are ureteric identification and conversion of methylene blue to leucomethylene blue.

Conditions

• Fluorescence Guided Surgery

Interventions

Type	Name	Description
DEVICE	Methylene blue fluorescence	IV administration of methylene blue, detection with deep infrared camera and light source

Timeline

• Start date: 2020-06-22
• Primary completion: 2023-07-01
• Completion: 2023-10-01
• First posted: 2021-11-08
• Last updated: 2022-11-01

Locations

1 site across 1 country: United Kingdom