Validation of ICG to Identify the Urethra During Rectal Surgery

Surgery Clinical Trial

Official title:

Validation of ICG to Identify the Urethra During Rectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03204201
• Other study ID #: 12748
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 11, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: August 2019
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Surgery
• Urethra Injury

Intervention

Drug:
• Indocyanine Green Solution
Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of urethras identified under white light and fluorescence		1 day
Secondary	Signal to background ratios between cohorts of patients with varying doses of ICG		1 day
Secondary	Subjective assessment of usefulness of technology during operative procedure		1 day
Secondary	Length of time of interruption in operative procedure to perform trial intervention		1 day
Secondary	Number of adverse events related to trial intervention		30 days