Bite BlockNCT04236297
Evaluation of Modified Bite-Block for Invasive Imaging Procedures
A study testing bite block in people with Bite Block, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bite Block
- What is being tested?
- bite block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Undergoing stand-alone transesophageal echocardiography exam under sedation or general anesthesia
- Undergoing procedure that requires transesophageal echocardiography exam during the procedure under general anesthesia
- Cardiology and cardiac anesthesiology echocardiographers performing transesophageal echocardiography exam who wish to participate
Who cannot join
- Less than 18 years of age
- Any procedure that does not require transesophageal echocardiography exam during the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Modified Bite-Block vs Standard Bite Block for Invasive Imaging Procedures
The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia.
These dental protector devices are class I devices which are exempt from the FDA 510(k) premarket notification requirements.
Read the detailed description
Bite block is a single-use medical device used to keep the mouth open during invasive imaging procedures and prevent the patient from biting the imaging probe.
The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography exam procedures in patients who are either sedated or under general anesthesia.
The commercially available bite blocks are almost exclusively made of hard plastic that does not conform well to the patient's mouth with additional protrusions used to secure the bite block in place that have the potential to cause patient injury. Hard plastic is used to prevent patient from biting down on the imaging probe while side protrusions are used to strap the bite block down to prevent dislodgment.
Modified bite block is made of softer material with improved mouth fit and no need for strapping the bite block to keep it in place. Softer material is more comfortable while the designs mimics mouth guard used in dentistry to protect patient's teeth and keep the bite block in place while sleeping.
The specific aims of this project include:
- assessment of patient comfort during invasive imaging procedure
- assessment of provider satisfaction with the bite block
- assessment of patient lip/gum/teeth injury after bite block use
- assessment of imaging probe damage after procedure
- assessment of bite block's ability to stay in place during procedure
- Conditions
- Bite Block
- Being tested
- bite block
- Keywords
- bite block, transesophageal echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bite blockDevice
Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block.
| Study group | Role | What they receive |
|---|---|---|
| Modified Bite Block | Other | Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used Receives: Device: bite block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral injury
Number of participants with oral injury (dental injury, lacerations/bruises on gums and lips) which will be determined by examination
Measured: Within 24 hours
Secondary outcomes (2)
Dislodgment
Number of participants with bite block dislodgment which will be determined by provider questionnaire
Measured: Within 24 hours
Provider satisfaction
Number of providers that would use standard or redesigned bite block again
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start22 Aug 2019
- Primary completion30 Aug 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bite BlockStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srdjan Jelacic, University of Washington
- Investigators
- Srdjan Jelacic, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236297
- Sponsor's protocol ID
- STUDY00004883
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2020
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Modified Bite-Block vs Standard Bite Block for Invasive Imaging Procedures
- ClinicalTrials.gov ID
- NCT04236297
- Acronym / sponsor ID
- STUDY00004883
- Conditions
- Bite Block
- Keywords
- bite block, transesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Jan 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 purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia.
These dental protector devices are class I devices which are exempt from the FDA 510(k) premarket notification requirements.
Detailed description
Bite block is a single-use medical device used to keep the mouth open during invasive imaging procedures and prevent the patient from biting the imaging probe.
The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography exam procedures in patients who are either sedated or under general anesthesia.
The commercially available bite blocks are almost exclusively made of hard plastic that does not conform well to the patient's mouth with additional protrusions used to secure the bite block in place that have the potential to cause patient injury. Hard plastic is used to prevent patient from biting down on the imaging probe while side protrusions are used to strap the bite block down to prevent dislodgment.
Modified bite block is made of softer material with improved mouth fit and no need for strapping the bite block to keep it in place. Softer material is more comfortable while the designs mimics mouth guard used in dentistry to protect patient's teeth and keep the bite block in place while sleeping.
The specific aims of this project include:
- assessment of patient comfort during invasive imaging procedure
- assessment of provider satisfaction with the bite block
- assessment of patient lip/gum/teeth injury after bite block use
- assessment of imaging probe damage after procedure
- assessment of bite block's ability to stay in place during procedure
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Bite Block | Other | Device: bite blockPatients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Undergoing stand-alone transesophageal echocardiography exam under sedation or general anesthesia
- Undergoing procedure that requires transesophageal echocardiography exam during the procedure under general anesthesia
- Cardiology and cardiac anesthesiology echocardiographers performing transesophageal echocardiography exam who wish to participate
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Any procedure that does not require transesophageal echocardiography exam during the procedure
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 |
|---|---|---|
| bite blockPhysicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block. | Device | Modified Bite Block |
Primary outcome
Oral injury
Time frame: Within 24 hours
Number of participants with oral injury (dental injury, lacerations/bruises on gums and lips) which will be determined by examination
2 secondary outcomes
Dislodgment
Time frame: Within 24 hours
Provider satisfaction
Time frame: Within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Srdjan Jelacic, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bite block in people with Bite Block, run by University of Washington at 1 site in United States.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 15 Apr 2022. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Oral injury (time frame: Within 24 hours). 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 15 Apr 2022.