NCT04544800

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

5 years

First QC Date

August 26, 2020

Last Update Submit

March 18, 2024

Conditions

Splints

Keywords

Upper Aerodigestive TractVisualizationSurgical Instrumentation

Outcome Measures

Primary Outcomes (2)

  • Patient Splint Satisfaction Questionnaire

    Self-administered, 6-item questionnaire to evaluate splint satisfaction.

    Immediately after the intervention/procedure/surgery

  • Physician Splint Satisfaction Questionnaire

    A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.

    Immediately after the intervention/procedure/surgery

Study Arms (1)

Use of Splint for UADT Visualization

EXPERIMENTAL

Use of device to view UADT

Device: Use of Splint for UADT Visualization

Interventions

Use of Splint for UADT VisualizationDEVICE

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

Use of Splint for UADT Visualization

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Require a procedure involving the upper aerodigestive tract (UADT)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

  • Douglas B Chepeha, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 10, 2020

Study Start

May 31, 2018

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Locations

CA(1)