Development of Upper Aerodigestive Tract Splint

University Health Network, Toronto

Status: Terminated

Conditions: Splints

Treatments: Device: Use of Splint for UADT Visualization

Study type: Interventional

Funder types: Other

Identifiers

NCT04544800

17-5577

Details and patient eligibility

About

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

Full description

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

Enrollment: 7 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Use of Splint for UADT Visualization

Experimental group

Description:

Use of device to view UADT

Treatment:

Device: Use of Splint for UADT Visualization