Monitoring Free Tissue Transfer Hemodynamics Using NIRS (NCT06661525) | Clinical Trial Compass
By InvitationNot Applicable
Monitoring Free Tissue Transfer Hemodynamics Using NIRS
Canada60 participantsStarted 2025-04-20
Plain-language summary
Free tissue transfer (FTT) is a surgical procedure for repairing cancer resection wounds. Free tissue transfer usually involves taking skin from one area of the body (e.g. leg) and transplanting it to the surgically created wound (e.g. neck wound). Due to problems with anastomosis, the transplanted skin can die. If the poor blood supply can be detected early, transplanted skin can be saved by taking patients back to the operating room. The investigators propose to improve the design and test a novel, non-invasive monitoring system specifically for head and neck surgeries for early detection of poor blood supply to the transplanted tissue after FTT surgery.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 60 patients undergoing a variety of free tissue transfer for head and neck cancer. The result of the reconstruction should be easily visible to the clinicians.
* Age of 18 years old or older
Exclusion Criteria:
* Serious medical condition or other disease which occurs at the same time
* Metastatic disease
* Pregnant or nursing
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Establish a baseline Total Oxygenation Index (TOI) to measure NIRS on FTT cases
Timeframe: Up to 36 months
2
Enhance the design and accuracy of the FTT- NIRS sensor based on patient and clinicians feedback