Development of Upper Aerodigestive Tract Splint

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04544800

Enrollment

Registered

2020-09-10

Start date

2018-05-31

Completion date

2023-05-31

Last updated

2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Splints

Keywords

Upper Aerodigestive Tract, Visualization, Surgical Instrumentation

Brief summary

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

Detailed description

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

Interventions

DEVICEUse of Splint for UADT Visualization

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026