Novel flexible bite block for outpatient upper endoscopy
A Novel Endoscopic Bite Block
This trial will test a new flexible bite block to see if it makes routine outpatient upper endoscopy safer and more efficient for adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Plainsboro, New Jersey) |
| Trial ID | NCT06958250 on ClinicalTrials.gov |
What this trial studies
This is a feasibility trial of a novel endoscopic bite block used during routine outpatient upper endoscopy to measure safety and effectiveness. Adult patients scheduled for upper endoscopy who consent will use the device during their procedure and investigators will track device-related complications, positioning issues, and procedural efficiency. Subjects with known allergy to thermoplastic polyurethane or other medical exclusions will be excluded. The study is conducted at a single site affiliated with the University of Pennsylvania.
Who should consider this trial
Good fit: Adults aged 21 and older who are scheduled for routine outpatient upper endoscopy and are judged appropriate by the endoscopy and anesthesia teams, and who can give informed consent, are ideal candidates.
Not a fit: Patients with a known allergy to thermoplastic polyurethane or those deemed unsuitable for outpatient upper endoscopy by the investigator are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, the device could reduce complications related to bite block positioning and improve procedure efficiency and patient safety during upper endoscopy.
How similar studies have performed: The device is novel and this is a feasibility test; while modified bite blocks have been used clinically, robust published data on this specific design are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Provision of a signed and dated Informed Consent Form (ICF). 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, ≥21 years of age. 4. Deemed appropriate for scheduled upper endoscopy by endoscopists and anesthesia staff. Exclusion Criteria 1. Known allergic reactions to thermoplastic polyurethane (TPU), the component used in the manufacturing of the Flexible Endoscopic Bite Block. 2. Any medical condition that, in the opinion of the PI, makes the subject ineligible to participate in the clinical trial.
Where this trial is running
Plainsboro, New Jersey
- Penn Medicine Princeton Health — Plainsboro, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Monica Saumoy, MD, MS
- Email: Monica.Saumoy@pennmedicine.upenn.edu
- Phone: 609-853-6390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.