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NCT04544800 Clinical Trial

Development of Upper Aerodigestive Tract Splint

Splints Clinical Trial

Official title:
Development of Upper Aerodigestive Tract Splint

Clinical Trial Details — Status: Terminated

Administrative data
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

Study information
Verified date March 2024
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.

Description:

This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Use of Splint for UADT Visualization
The use of a splint to assist the patient and the surgeon with UADT procedures.

Locations
Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
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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