Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
Recruiting
Phase 2
Interventional Study
Surgery Site Fistula
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- University Health Network, Toronto · Other
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About This Trial
A laryngectomy involves removing the voice box from the throat. After the voice box has been removed from the throat, the surgeon sews the throat closed. Sometimes part of the throat does not heal and saliva runs out of the throat. This is called a fistula. When a fistula happens, healing takes longer and patients will have to wait to eat and start speaking. The test in this research project is ca…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed written and voluntary informed consent.
* Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
* Age \> 18 years, male or female.
* Patient must be undergoing salvage laryngectomy after radiation …
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