Development of Upper Aerodigestive Tract Splint

March 18, 2024 updated by: University Health Network, Toronto
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Splint Satisfaction Questionnaire
Time Frame: Immediately after the intervention/procedure/surgery
Self-administered, 6-item questionnaire to evaluate splint satisfaction.
Immediately after the intervention/procedure/surgery
Physician Splint Satisfaction Questionnaire
Time Frame: Immediately after the intervention/procedure/surgery
A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.
Immediately after the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Douglas B Chepeha, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2018

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-5577

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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