Splints Clinical Trial
Official title:
Development of Upper Aerodigestive Tract Splint
NCT number | NCT04544800 |
Other study ID # | 17-5577 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | May 31, 2018 |
Est. completion date | May 31, 2023 |
Verified date | March 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.
Status | Terminated |
Enrollment | 7 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Require a procedure involving the upper aerodigestive tract (UADT) 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Splint Satisfaction Questionnaire | Self-administered, 6-item questionnaire to evaluate splint satisfaction. | Immediately after the intervention/procedure/surgery | |
Primary | Physician Splint Satisfaction Questionnaire | A 14-item questionnaire to evaluate the surgeon satisfaction with the splint. | Immediately after the intervention/procedure/surgery |
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