Endoscopy, Digestive SystemOBBNCT07086378
Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block
A study testing Oxygenating Bite Block in people with Endoscopy, Digestive System and Airway Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy, Digestive System, Airway Anesthesia, Airway Control
- What is being tested?
- Oxygenating Bite Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2025to 2 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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.
- Being tested
- Oxygenating Bite Block
- Keywords
- airway management, Upper endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygenating Bite BlockDevice
Oxygenating Bite Block will be used instead of the standard bite block.
| Study group | Role | What they receive |
|---|---|---|
| Oxygenating Bite Block (OBB) | Experimental | 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. Receives: Device: Oxygenating Bite Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
OBB Device Feasibility
SPO2 -Subject desaturation
Measured: During the upper endoscopy procedure
Secondary outcomes (3)
Tolerability of the Oxygenating Bite Block - Patients
Questionnaire Satisfaction with the level of sedation and OBB tolerability?
Measured: After the endoscopy, up to 5 minutes
Tolerability of the Oxygenating Bite Block - Anesthesiologist
Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively?
Measured: After the endoscopy, up to 5 minutes
Tolerability of the Oxygenating Bite Block - Endoscopist
Questionnaire - Endoscopist Did your patient tolerate the OBB well, and will you use it again?
Measured: After the endoscopy, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start28 Jul 2025
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endoscopy, Digestive SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study (ten subjects)
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Wong, Cedars-Sinai Medical Center
- Investigators
- Robert Wong, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086378
- Sponsor's protocol ID
- STUDY00003021
- Acronym
- OBB
- Status last verified
- Dec 2025
- First submitted
- 29 May 2025
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: It is a small sample, only 10 subjects, it is a pilot study
Publications
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.
PubMed 26134777Qadeer 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.
PubMed 19003534
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block
- ClinicalTrials.gov ID
- NCT07086378
- Acronym / sponsor ID
- OBB / STUDY00003021
- Keywords
- airway management, Upper endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 25 Jul 2025 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study (ten subjects)
| Arm | Type | Receives |
|---|---|---|
| Oxygenating Bite Block (OBB) | Experimental | Device: Oxygenating Bite BlockDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygenating Bite BlockOxygenating Bite Block will be used instead of the standard bite block. | Device | Oxygenating Bite Block (OBB) |
Primary outcome
OBB Device Feasibility
Time frame: During the upper endoscopy procedure
SPO2 -Subject desaturation
3 secondary outcomes
Tolerability of the Oxygenating Bite Block - Patients
Time frame: After the endoscopy, up to 5 minutes
Tolerability of the Oxygenating Bite Block - Anesthesiologist
Time frame: After the endoscopy, up to 5 minutes
Tolerability of the Oxygenating Bite Block - Endoscopist
Time frame: After the endoscopy, up to 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26134777de 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.
- Background: PubMed 19003534Qadeer 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.
- Individual participant dataSharing planned: No. It is a small sample, only 10 subjects, it is a pilot study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Wong, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygenating Bite Block in people with Endoscopy, Digestive System and Airway Anesthesia, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OBB Device Feasibility (time frame: During the upper endoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07086378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.