NIRCa Pilot Study
Research type
Research Study
Full title
A new near infrared catheter adapter to highlight the urethra during low rectal surgery
IRAS ID
228542
Contact name
Thomas Barnes
Contact email
Sponsor organisation
Clinical Trials and Research Governance
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
During certain types of surgery on the rectum there is a risk of injuring the urethra (tube which transports urine from the bladder to outside of the body). We have performed a study on human cadavers that shows that using ICG (indocyanine green) near infra-red fluorescence may help the surgeon identify the location of the urethra and therefore protect it. Near infra-red fluorescence is using light that is outside of the visible light spectrum, also known as "invisible light". It can be viewed using cameras with special filters that then display the near infra-red light to the surgeon on screen.
We have designed a near infra-red adapter which can be used with a standard urinary Foley catheter to emit near-infra-red light.
This is a feasibility study where the primary objective is to assess the feasibility of using our device to highlight the urethra during low rectal surgery.
Patients undergoing low rectal surgery (usually for cancer) at a single site (Oxford University Hospitals NHS Foundation Trust) will be recruited to the study. For these types of operations patients routinely have a urinary Foley catheter inserted for the duration of the procedure and for post-operative monitoring. These catheters are placed via the urethra into the bladder. The adapter we have designed is inserted into the Foley catheter prior to its insertion into the patient using the standard technique. The adapter is then connected to a light source which emits near infra-red light. A camera which we use routinely in our hospital can visualise the light. At the end of the operation the adapter will be removed from the Foley catheter which is left in situ as is the standard practice.
Participants recruited to the trial will have this single intervention on the day of their operation. There are no other visits or interventions for participants.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
17/NW/0479
Date of REC Opinion
16 Aug 2017
REC opinion
Favourable Opinion