Novel Endoscopic Bite Block

NCT ID: NCT06958250

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-22

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Novel Bite Block

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

Group Type EXPERIMENTAL

Novel Bite Block

Intervention Type DEVICE

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

Interventions

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Novel Bite Block

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anish Sheth, MD, AGAF

Role: STUDY_DIRECTOR

Penn Medicine Princeton Health

Locations

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Penn Medicine Princeton Health

Plainsboro, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Saumoy, MD, MS

Role: CONTACT

609-853-6390

Sheryl Smolensky, RN, MSN, OCN

Role: CONTACT

609-853-6775

Facility Contacts

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Monica Saumoy, MD, MS

Role: primary

609-853-6390

Sheryl Smolensky, RN, MSN, OCN

Role: backup

609-853-6775

Other Identifiers

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857779

Identifier Type: -

Identifier Source: org_study_id

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