Development of Upper Aerodigestive Tract Splint
Sponsor
University Health Network, Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04544800
Collaborator
(none)
30
1
1
72
0.4
Study Details
Study Description
Brief Summary
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Development of Upper Aerodigestive Tract Splint
Actual Study Start Date
:
May 31, 2018
Anticipated Primary Completion Date
:
May 31, 2023
Anticipated Study Completion Date
:
May 31, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Use of Splint for UADT Visualization Use of device to view UADT |
Device: Use of Splint for UADT Visualization
The use of a splint to assist the patient and the surgeon with UADT procedures.
|
Outcome Measures
Primary Outcome Measures
- Patient Splint Satisfaction Questionnaire [Immediately after the intervention/procedure/surgery]
Self-administered, 6-item questionnaire to evaluate splint satisfaction.
- Physician Splint Satisfaction Questionnaire [Immediately after the intervention/procedure/surgery]
A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Health Network | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
Investigators
- Principal Investigator: Douglas B Chepeha, MD, University Health Network, Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT04544800
Other Study ID Numbers:
- 17-5577
First Posted:
Sep 10, 2020
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Health Network, Toronto