SplintsNCT04544800
Development of Upper Aerodigestive Tract Splint
A study testing Use of Splint for UADT Visualization in people with Splints, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Splints
- What is being tested?
- Use of Splint for UADT Visualization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2018to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Require a procedure involving the upper aerodigestive tract (UADT)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.
Read the detailed description
This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.
- Conditions
- Splints
- Being tested
- Use of Splint for UADT Visualization
- Keywords
- Upper Aerodigestive Tract, Visualization, Surgical Instrumentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Splint for UADT VisualizationDevice
The use of a splint to assist the patient and the surgeon with UADT procedures.
| Study group | Role | What they receive |
|---|---|---|
| Use of Splint for UADT Visualization | Experimental | Use of device to view UADT Receives: Device: Use of Splint for UADT Visualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Splint Satisfaction Questionnaire
Self-administered, 6-item questionnaire to evaluate splint satisfaction.
Measured: Immediately after the intervention/procedure/surgery
Physician Splint Satisfaction Questionnaire
A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.
Measured: Immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start31 May 2018
- Primary completion31 May 2023
- Study completion31 May 2023
Why it stopped: PI Relocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SplintsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas B Chepeha, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544800
- Sponsor's protocol ID
- 17-5577
- Status last verified
- Mar 2024
- First submitted
- 26 Aug 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Upper Aerodigestive Tract Splint
- ClinicalTrials.gov ID
- NCT04544800
- Acronym / sponsor ID
- 17-5577
- Conditions
- Splints
- Keywords
- Upper Aerodigestive Tract, Visualization, Surgical Instrumentation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Relocation
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of Splint for UADT Visualization | Experimental | Device: Use of Splint for UADT VisualizationUse of device to view UADT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Require a procedure involving the upper aerodigestive tract (UADT)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Splint for UADT VisualizationThe use of a splint to assist the patient and the surgeon with UADT procedures. | Device | Use of Splint for UADT Visualization |
Primary outcome
Patient Splint Satisfaction Questionnaire
Time frame: Immediately after the intervention/procedure/surgery
Self-administered, 6-item questionnaire to evaluate splint satisfaction.
Physician Splint Satisfaction Questionnaire
Time frame: Immediately after the intervention/procedure/surgery
A 14-item questionnaire to evaluate the surgeon satisfaction with the splint.
Results and safety
The study was stopped early (reason given: PI Relocation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas B Chepeha, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Splint for UADT Visualization in people with Splints, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Relocation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Splint Satisfaction Questionnaire (time frame: Immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.