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Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

NCT ID: NCT07086378

Last Updated: 2025-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-28

Study Completion Date

2025-12-02

Brief Summary

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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

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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

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Endoscopy, Digestive System Airway Anesthesia Airway Control Airway Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study (ten subjects)
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Oxygenating Bite Block (OBB)

During the endoscopy procedure, the oxygenating bite block will be placed in the mouth instead of the standard and customary bite block.

After the endoscopy procedure, the participant will be asked to complete a short questionnaire to find out their satisfaction with the level of sedation during the procedure, the tolerability of the device, and any discomfort.

Group Type EXPERIMENTAL

Oxygenating Bite Block

Intervention Type DEVICE

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

Interventions

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Oxygenating Bite Block

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Robert Wong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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de Paulo GA, Martins FP, Macedo EP, Goncalves ME, Mourao CA, Ferrari AP. Sedation in gastrointestinal endoscopy: a prospective study comparing nonanesthesiologist-administered propofol and monitored anesthesia care. Endosc Int Open. 2015 Feb;3(1):E7-E13. doi: 10.1055/s-0034-1377835. Epub 2015 Jan 16.

Reference Type BACKGROUND
PMID: 26134777 (View on PubMed)

Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.

Reference Type BACKGROUND
PMID: 19003534 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

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STUDY00003021

Identifier Type: -

Identifier Source: org_study_id