CompletedNot Applicable

Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

United States10 participantsStarted 2025-07-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Obese patients scheduled to undergo upper endoscopy, * Willingness and ability to sign an informed consent document, * ASA class I - III obese adults, * Subjects will be of diverse racial and ethnic backgrounds. Exclusion Criteria: * Patients deemed to be at significant airway risk, * Under 18 years of age, since there is no justification to include them, * Missing or loose incisor or canine teeth * Temporomandibular joint disease * Maxillofacial abnormalities (deformities of the jaw, lips, and tongue) * Pregnant women, since there is no justification to include them, * Emergency surgeries, * Any other conditions that may interfere with the conduct of the study.

What they're measuring

OBB Device Feasibility

Timeframe: During the upper endoscopy procedure

Trial details

NCT IDNCT07086378

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-02

Results submitted2025-12-01

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