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

NCT05111808 | Unknown

• 1 other identifier: 120726
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fluorescence Guided Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment to study

  Feasibility of recruitment to the study. This will be recorded in the screening log. The number of patients able partake in the study will be expressed as a percentage of the number of patients approached for consent. Patients will be excluded if the do not meet the inclusion/exclusion criteria or do not consent.

  12 months

Secondary Outcomes (2)

• Rate of ureteric identification and signal intensity at defined time points

  12 months

• Percentage conversion of methylene blue to leucomethylene blue at defined time points

  12 months

Study Arms (1)

Methyl Blue

EXPERIMENTAL

This group will receive intraoperative IV methyl blue

Device: Methylene blue fluorescence

Interventions

Methylene blue fluorescence DEVICE

IV administration of methylene blue, detection with deep infrared camera and light source

Methyl Blue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Renal dysfunction defined as estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2
• Has participated in another investigational study within 30 days prior to surgery
• Pregnant or lactating subjects
• Subjects who, in the Investigator's and/or designee'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

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospital

London, United Kingdom

RECRUITING

Study Officials

• Manish Chand, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Pampiglione

CONTACT

02034567890; tom.pampiglione@nhs.net

UCLH JRO

CONTACT

02034567890; uclh.randd@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 8, 2021
• Study Start: June 22, 2020
• Primary Completion: July 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)