Validation of ICG to Identify the Urethra During Rectal S... | NCT03204201

Studies
Validation of ICG to Identify the Urethra During Rectal Surgery

NCT03204201

Sponsor

Oxford University Hospitals NHS Trust

Status

Terminated

Last Update Posted

Aug 13, 2019Actual

Enrollment

5Actual

Phase

Phase 1Phase 2

Conditions

Urethra Injury
Rectal Cancer
Surgery

Interventions

Indocyanine Green Solution

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Technique failed

Expanded Access Info

Start Date

Jul 11, 2017Actual

Primary Completion Date

Jul 1, 2018Actual

Completion Date

Aug 1, 2018Actual

First Submitted Date

Jun 28, 2017

First Submission Date that Met QC Criteria

Jun 28, 2017

First Posted Date

Jun 29, 2017Actual

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

Aug 10, 2019

Last Update Posted Date

Aug 13, 2019Actual

Name	Class
University of Oxford	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 an open-label feasibility study utilising direct instillation of ICG into the urethra during surgery for low rectal cancers. The trial involves a single intervention taking place during the patient's operation. Participants will be included in the study for around 2 months with time either side of the intervention to collect background data.

Detailed Description

Not provided

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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Urethral instillation of ICG	Experimental	Urethral instillation of indocyanine green (ICG)	Drug: Indocyanine Green Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indocyanine Green Solution	Drug	Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant	Urethral instillation of ICG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of urethras identified under white light and fluorescence		1 day

Secondary Outcomes

Measure	Description	Time Frame
Signal to background ratios between cohorts of patients with varying doses of ICG		1 day
Subjective assessment of usefulness of technology during operative procedure		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant is willing and able to give informed consent for participation in the study.
Male, aged 18 years or above.
Undergoing low rectal surgery where the operating field will be close to the urethra

Exclusion Criteria:

Participant has an allergy to iodine or ICG
Known liver failure

Accepts Healthy Volunteers

Yes

Sex

Male

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

Not provided

Overall Officials

Name	Affiliation	Role
Roel Hompes, MD	Consultant Colorectal Surgeon	Principal Investigator
Thomas Barnes, MBChB	Clinical Research Fellow	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oxford University Hospitals NHS Foundation Trust		Oxford	Oxfordshire	OX3 7LE	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual participant data to be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided