Fluorescent Imaging & Methylene Blue: Ureter Study

What Was Tested

This registered phase 2 trial tested Methylene blue (non-peptide stack partner).

The main aim of this project is to assess whether intravenous methylene blue can help identify the ureters during open and laparoscopic (keyhole) surgery.

The ureters are small tubes that link the kidney to the bladder and, if not properly identified during surgery, may be damaged.

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

Intravenous administration of methylene blue and assessment of ureteric fluorescence intraoperatively.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 50 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 years or above. Patients undergoing laparoscopic or open colorectal surgery. In the Investigator's opinion, is able and willing to comply with all study requirements.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patient who is unable or unwilling to give informed consent; female participant who is pregnant, lactating or planning pregnancy during the course of the trial; any patients with previous allergies to methylene blue.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

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

It started in 2016-05-09 with completion listed for 2017-05-02.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: To compare the change in ureter identification over time using white light versus intravenous methylene blue in each patient.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Methylene blue (non-peptide stack partner) in 50 people.

The trial is marked completed; 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.