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

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

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.

It had 1 arm (groups): Methyl Blue (experimental).

This group will receive intraoperative IV methyl blue.

The registry classes the interventions as device.

More on the Plan

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.

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.

Methods - In this study, patients undergoing abdominal surgery with high risk for ureter complications will be included.

Who Took Part

Enrollment: 10 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18 years of age or older. Scheduled for a surgery where routine ureter identification is used. Have signed an approved informed consent form for the study. Be willing and able to comply with the study protocol.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: known allergy or history of adverse reaction to methylene blue; taking an antidepressant including, but not limited, to selective and non-selective serotonin reuptake inhibitors, or a psychiatric medication; glucose-6-phosphate dehydrogenase (g6pd) deficiency.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-06-22 with completion listed for 2023-07-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is device feasibility.

What Was Measured

Researchers chose this as the main measure: Rate of recruitment to study (time frame: 12 months).

It also tracked 2 secondary outcomes, for example Rate of ureteric identification and signal intensity at defined time points and Percentage conversion of methylene blue to leucomethylene blue at defined time points.

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 10 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.