BridgeMD
New treatment option for Surgery Site Fistula
Official title Hypopharynx ICG to Reduce the Fistula Rate in Patients Undergoing Salvage Laryngectomy
ClinicalTrials.gov ID: NCT05350540
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 or chemoradiation. By definition, the patients are considered resectable by the...
- The expected pharyngeal defect must be conducive to imaging with the ICG.
You likely can't join if
- Total Laryngopharyngectomy
- On immune suppression medications
- Current hematologic malignancy
- Pregnancy
- Allergy to Iodine
- TSH greater than 8
See the full eligibility 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 or chemoradiation. By definition, the patients are considered resectable by the treating head and neck surgeon.
- The expected pharyngeal defect must be conducive to imaging with the ICG.
- Vascularized tissue augmentation (flap) is part of the operative plan (supra- or infraclavicular flap excludes the patient).
- ECOG performance status 0-2.
- Total Laryngopharyngectomy
- On immune suppression medications
- Current hematologic malignancy
- Pregnancy
- Allergy to Iodine
- TSH greater than 8
- BMI less than 18
- Vascularized augmentation is a supra or infraclavicular rotational flap
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.