Novel Endoscopic Bite Block

A Novel Endoscopic Bite Block

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06958250

Enrollment

Registered

2025-05-06

Start date

2025-12-22

Completion date

2026-05-28

Last updated

2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Disease

Brief 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.

Interventions

DEVICENovel Bite Block

The endoscopist will utilize the Novel Endoscopic Bite Block for the duration of the upper endoscopy (single-use, disposable).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory	Day of procedure	Proportion of endoscopic procedures that are successfully completed
Absence of dental injury during the upper endoscopy	Day of procedure	Number and type of dental injuries occurred during the upper endoscopy

Secondary

Measure	Time frame	Description
Endoscopist's satisfaction with lack of bite block movement	Day of procedure	Proportion of endoscopic procedures assessed by the endoscopist as satisfactory

Countries

United States

Contacts

STUDY_DIRECTORAnish Sheth, MD, AGAF

Penn Medicine Princeton Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026