Novel Endoscopic Bite Block

University of Pennsylvania

Status: Begins enrollment in 1 month

Conditions: Gastric Disease

Treatments: Device: Novel Bite Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06958250

857779

Details and patient eligibility

About

This study will test a novel endoscopic bite block during upper endoscopy.

Full description

This study will feasibility and comfort of the novel endoscopic bite block that contains a compressible addition to the traditional endoscopic bite block offering cushioning for the teeth and the ability to resist mispositioning when a patient opens their mouth (ie, during a yawn).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, > 18 years of age
4. Deemed appropriate for scheduled upper endoscopy by endoscopy and anesthesia staff

Exclusion Criteria:

1. Known allergic reactions to components of the novel endoscopic bite block

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Novel Bite Block

Experimental group

Description:

Patients will utilize the novel Bite Block during routine endoscopic procedure

Treatment:

Device: Novel Bite Block