NCT07086378

Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test an investigational bite block, which is a device placed inside the mouth to protect the teeth and used to keep the endoscope (a long, flexible tube that is placed down the throat and into the esophagus that contains a light and camera used to provide a visual of the area) in place. This Oxygenating bite block has been modified to allow the convenient use of an oral nasal cannula for administration of oxygen and sampling of end-tidal carbon dioxide (measurement of the amount of carbon dioxide exhaled at the end of a breath) during endoscopic procedures.

Detailed description

This study will last one day and is completely voluntary. The primary objective of this study is to evaluate the tolerability and efficacy of the device. The investigator will be testing how this device improves the flow of oxygen and provides safer sedation.

Conditions

• Endoscopy, Digestive System
• Airway Anesthesia
• Airway Control
• Airway Management

Interventions

Type	Name	Description
DEVICE	Oxygenating Bite Block	Oxygenating Bite Block will be used instead of the standard bite block.

Timeline

• Start date: 2025-07-28
• Primary completion: 2025-12-02
• Completion: 2025-12-02
• First posted: 2025-07-25
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study