Novel Endoscopic Bite Block

NCT06958250 | Recruiting FDA Device

• 1 other identifier: 857779
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Disease

Outcome Measures

Primary Outcomes (2)

• Successful completion of upper endoscopy procedures with the Novel Endoscopic Bite Block accessory

  Proportion of endoscopic procedures that are successfully completed

  Day of procedure

• Absence of dental injury during the upper endoscopy

  Number and type of dental injuries occurred during the upper endoscopy

  Day of procedure

Secondary Outcomes (1)

• Endoscopist's satisfaction with lack of bite block movement

  Day of procedure

Study Arms (1)

Novel Bite Block

EXPERIMENTAL

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

Device: Novel Bite Block

Interventions

Novel Bite Block DEVICE

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

Novel Bite Block

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of a signed and dated Informed Consent Form (ICF).
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, ≥21 years of age.
• Deemed appropriate for scheduled upper endoscopy by endoscopists and anesthesia staff.

You may not qualify if:

• Known allergic reactions to thermoplastic polyurethane (TPU), the component used in the manufacturing of the Flexible Endoscopic Bite Block.
• Any medical condition that, in the opinion of the PI, makes the subject ineligible to participate in the clinical trial.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Medicine Princeton Health

Plainsboro, New Jersey, 08536, United States

RECRUITING

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anish Sheth, MD, AGAF

  Penn Medicine Princeton Health

  STUDY DIRECTOR

Central Study Contacts

Monica Saumoy, MD, MS

CONTACT

609-853-6390; Monica.Saumoy@pennmedicine.upenn.edu

Sheryl Smolensky, RN, MSN, OCN

CONTACT

609-853-6775; sheryl.smolensky@PennMedicine.Upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: May 6, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)