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OpenTrials
Completed

NCT Number: NCT06958250

Novel Endoscopic Bite Block

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.

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Key information

Conditions

Gastric Disease Digestive System Diseases Gastrointestinal Diseases Stomach Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn Medicine Princeton Health

Plainsboro, New Jersey, 08536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Novel Bite Block

Device

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

Primary outcomes

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

    Time frame: Day of procedure

    Proportion of endoscopic procedures that are successfully completed

  2. Absence of dental injury during the upper endoscopy

    Time frame: Day of procedure

    Number and type of dental injuries occurred during the upper endoscopy

Secondary outcomes

  1. Endoscopist's satisfaction with lack of bite block movement

    Time frame: Day of procedure

    Proportion of endoscopic procedures assessed by the endoscopist as satisfactory

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

A Novel Endoscopic Bite Block

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 6, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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