A Novel Endoscopic Bite Block
University of Pennsylvania
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. The investigator hypothesizes that its innovative design will reduce complications associated with bite block positioning, thereby improving procedural efficiency and patient safety.
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DeviceNovel Bite Block
The endoscopist will utilize the Novel Endoscopic Bite Block for the duration of the upper endoscopy (single-use, disposable).
Location
- Penn Medicine Princeton HealthPlainsboro, New Jersey