Novel Endoscopic Bite Block

University of Pennsylvania

Status: Enrolling

Conditions: Gastric Disease

Treatments: Device: Novel Bite Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06958250

857779

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Novel Bite Block

Experimental group

Description:

Insertion of Novel Endoscopic Bite Block in the subject's mouth following the usual manner prior to endoscopic procedure.

Treatment:

Device: Novel Bite Block