Gastric DiseaseNCT06958250
Novel Endoscopic Bite Block
A study testing Novel Bite Block in people with Gastric Disease, run by University of Pennsylvania at 1 site in United States.
Trial summary
This feasibility study aims to assess the safety and effectiveness of the Novel Endoscopic Bite Block. The device will be utilized in subjects undergoing routine outpatient upper endoscopy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Gastric Disease
- What is being tested?
- Novel Bite Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to 28 May 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of a signed and dated Informed Consent Form (ICF).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ≥21 years of age.
- Deemed appropriate for scheduled upper endoscopy by endoscopists and anesthesia staff.
Who cannot join
- Known allergic reactions to thermoplastic polyurethane (TPU), the component used in the manufacturing of the Flexible Endoscopic Bite Block.
- Any medical condition that, in the opinion of the PI, makes the subject ineligible to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536
About this study
Official title: A Novel Endoscopic Bite Block
This feasibility study aims to assess the safety and effectiveness of the Novel Endoscopic Bite Block. The device will be utilized in subjects undergoing routine outpatient upper endoscopy. The investigator hypothesizes that its innovative design will reduce complications associated with bite block positioning, thereby improving procedural efficiency and patient safety.
- Conditions
- Gastric Disease
- Being tested
- Novel Bite Block
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Bite BlockDevice
The endoscopist will utilize the Novel Endoscopic Bite Block for the duration of the upper endoscopy (single-use, disposable).
| Study group | Role | What they receive |
|---|---|---|
| Novel Bite Block | Experimental | Insertion of Novel Endoscopic Bite Block in the subject's mouth following the usual manner prior to endoscopic procedure. Receives: Device: Novel Bite Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory
Proportion of endoscopic procedures that are successfully completed
Measured: Day of procedure
Absence of dental injury during the upper endoscopy
Number and type of dental injuries occurred during the upper endoscopy
Measured: Day of procedure
Secondary outcomes (1)
Endoscopist's satisfaction with lack of bite block movement
Proportion of endoscopic procedures assessed by the endoscopist as satisfactory
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start22 Dec 2025
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anish Sheth, MD, AGAF, Study director, Penn Medicine Princeton Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958250
- Sponsor's protocol ID
- 857779
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Endoscopic Bite Block
- ClinicalTrials.gov ID
- NCT06958250
- Acronym / sponsor ID
- 857779
- Conditions
- Gastric Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 6 May 2025 (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.
This feasibility study aims to assess the safety and effectiveness of the Novel Endoscopic Bite Block. The device will be utilized in subjects undergoing routine outpatient upper endoscopy. The investigator hypothesizes that its innovative design will reduce complications associated with bite block positioning, thereby improving procedural efficiency and patient safety.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Bite Block | Experimental | Device: Novel Bite BlockInsertion of Novel Endoscopic Bite Block in the subject's mouth following the usual manner prior to endoscopic procedure. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of a signed and dated Informed Consent Form (ICF).
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female, ≥21 years of age.
- Deemed appropriate for scheduled upper endoscopy by endoscopists and anesthesia staff.
Key exclusion criteria (2 listed)
- Known allergic reactions to thermoplastic polyurethane (TPU), the component used in the manufacturing of the Flexible Endoscopic Bite Block.
- Any medical condition that, in the opinion of the PI, makes the subject ineligible to participate in the clinical trial.
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 |
|---|---|---|
| Novel Bite BlockThe endoscopist will utilize the Novel Endoscopic Bite Block for the duration of the upper endoscopy (single-use, disposable). | Device | Novel Bite Block |
Primary outcome
Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory
Time frame: Day of procedure
Proportion of endoscopic procedures that are successfully completed
Absence of dental injury during the upper endoscopy
Time frame: Day of procedure
Number and type of dental injuries occurred during the upper endoscopy
1 secondary outcome
Endoscopist's satisfaction with lack of bite block movement
Time frame: Day of procedure
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 2 Jun 2026.
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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.
Anish Sheth, MD, AGAF study director
Penn Medicine Princeton Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Bite Block in people with Gastric Disease, run by University of Pennsylvania 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 2 Jun 2026. 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?
Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory (time frame: Day of procedure). 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 2 Jun 2026.