Trial Outcomes & Findings for Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block (NCT NCT07086378)

NCT ID: NCT07086378

Last Updated: 2025-12-16

Results Overview

SPO2 -Subject desaturation

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

During the upper endoscopy procedure

Results posted on

2025-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Oxygenating Bite Block (OBB) During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxygenating Bite Block (OBB) n=10 Participants During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block.
Age, Continuous	59 years STANDARD_DEVIATION 13 • n=6 Participants
Sex: Female, Male Female	7 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	3 Participants n=6 Participants
Race (NIH/OMB) White	7 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Region of Enrollment United States	10 Participants n=6 Participants

PRIMARY outcome

Timeframe: During the upper endoscopy procedure

Population: SpO2 \< 90%

SPO2 -Subject desaturation

Outcome measures

Outcome measures
Measure	Oxygenating Bite Block (OBB) n=10 Participants During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block.
OBB Device Feasibility	3 Participants

SECONDARY outcome

Timeframe: After the endoscopy, up to 5 minutes

Population: All subjects (100%) expressed satisfaction with the level of sedation and OBB tolerability

Questionnaire Satisfaction with the level of sedation and OBB tolerability?

Outcome measures

Outcome measures
Measure	Oxygenating Bite Block (OBB) n=10 Participants During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block.
Tolerability of the Oxygenating Bite Block - Patients	10 Participants

SECONDARY outcome

Timeframe: After the endoscopy, up to 5 minutes

Population: Anesthesiologists expressed that the OBB was easy to use, protected the subject's oral cavity, and oxygenated effectively.

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

Outcome measures

Outcome measures
Measure	Oxygenating Bite Block (OBB) n=10 Participants During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block.
Tolerability of the Oxygenating Bite Block - Anesthesiologist	10 Participants

SECONDARY outcome

Timeframe: After the endoscopy, up to 5 minutes

Population: Endoscopists expressed that the OBB was well tolerated and will you use it again.

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

Outcome measures

Outcome measures
Measure	Oxygenating Bite Block (OBB) n=10 Participants During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block.
Tolerability of the Oxygenating Bite Block - Endoscopist	10 Participants

Adverse Events

Oxygenating Bite Block (OBB)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Wong

Cedars Sinai Medical Center

Phone: 3104231682

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place