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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Endoscopy, Digestive System trials