Development of Upper Aerodigestive Tract Splint

NCT ID: NCT04544800

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2023-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Splints

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Use of Splint for UADT Visualization

Use of device to view UADT

Group Type EXPERIMENTAL

Use of Splint for UADT Visualization

Intervention Type DEVICE

The use of a splint to assist the patient and the surgeon with UADT procedures.

Interventions

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Use of Splint for UADT Visualization

The use of a splint to assist the patient and the surgeon with UADT procedures.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas B Chepeha, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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17-5577

Identifier Type: -

Identifier Source: org_study_id

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