Feasibility Trial for Real-time Identification of the Ure... | NCT05111808

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

NCT05111808

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Nov 1, 2022Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Fluorescence Guided Surgery

Interventions

Methylene blue fluorescence

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 22, 2020Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Oct 1, 2023Estimated

First Submitted Date

Oct 12, 2021

First Submission Date that Met QC Criteria

Oct 26, 2021

First Posted Date

Nov 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2022

Last Update Posted Date

Nov 1, 2022Actual

Name	Class
University College London Hospitals	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methyl Blue	Experimental	This group will receive intraoperative IV methyl blue	Device: Methylene blue fluorescence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylene blue fluorescence	Device	IV administration of methylene blue, detection with deep infrared camera and light source	Methyl Blue

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Rate of ureteric identification and signal intensity at defined time points	The operation will be paused and image switched to the Pinpoint camera at 5, 10, 15, 20, 30 and 40 minutes. The signal to background ratio will be calculated from the near infra-red images. This will allow us to quantify the fluorescence of methylene blue under near infra-red light.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tom Pampiglione	Contact	02034567890		tom.pampiglione@nhs.net
UCLH JRO	Contact	02034567890		uclh.randd@nhs.net

Overall Officials

Name	Affiliation	Role
Manish Chand, PhD	University College, London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University College London Hospital	Recruiting	London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided