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Completed

NCT Number: NCT07086378

Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

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.

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Key information

Conditions

Endoscopy, Digestive System Airway Anesthesia Airway Control Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Oxygenating Bite Block

Device

Oxygenating Bite Block will be used instead of the standard bite block.

Primary outcomes

  1. OBB Device Feasibility

    Time frame: During the upper endoscopy procedure

    SPO2 -Subject desaturation

Secondary outcomes

  1. Tolerability of the Oxygenating Bite Block - Patients

    Time frame: After the endoscopy, up to 5 minutes

    Questionnaire Satisfaction with the level of sedation and OBB tolerability?

  2. Tolerability of the Oxygenating Bite Block - Anesthesiologist

    Time frame: After the endoscopy, up to 5 minutes

    Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively?

  3. Tolerability of the Oxygenating Bite Block - Endoscopist

    Time frame: After the endoscopy, up to 5 minutes

    Questionnaire - Endoscopist Did your patient tolerate the OBB well, and will you use it again?

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Acronym: OBB

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2025
Registry last updated
Dec 16, 2025

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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