Development of Upper Aerodigestive Tract Splint
Not Applicable
Terminated
- Conditions
- Splints
- Interventions
- Device: Use of Splint for UADT Visualization
- Registration Number
- NCT04544800
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.
- Detailed Description
This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Require a procedure involving the upper aerodigestive tract (UADT)
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Exclusion Criteria
- Prior surgery to tongue or mouth that precludes the use of the splint
- Trismus with mouth opening that does not allow for use of the splint
- TMJ dysfunction that precludes the use of the splint
- Allergy to local anesthetic
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Use of Splint for UADT Visualization Use of Splint for UADT Visualization Use of device to view UADT
- Primary Outcome Measures
Name Time Method Physician Splint Satisfaction Questionnaire Immediately after the intervention/procedure/surgery A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.
Patient Splint Satisfaction Questionnaire Immediately after the intervention/procedure/surgery Self-administered, 6-item questionnaire to evaluate splint satisfaction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Health Network
🇨🇦Toronto, Ontario, Canada