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New device aims to keep patients breathing safely during endoscopy

NCT ID NCT07623863

Symptom relief Sponsor: Qianfoshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device that combines a mouthpiece, airway support, oxygen delivery, and breathing monitoring into one tool for sedated endoscopy. About 1,500 adults will be randomly assigned to receive either this device or standard care. The goal is to see if it reduces episodes of low oxygen during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Novel Multifunctional Oropharyngeal Airway (device)
What this could lead to
If it works, this device could reduce dangerous drops in oxygen levels during sedated endoscopy, making the procedure safer for patients.
What could go wrong
This is an early-stage trial with no phase designation, so results are uncertain. The device may not perform better than standard care, and risks like discomfort or airway injury are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,518 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-80 years; * BMI: 18-30 kg/m²; * ASA class I-II; * Scheduled to undergo elective sedated gastrointestinal endoscopy; * Willing to participate in this study and able to provide written informed consent. Exclusion Criteria: * Diagnosed respiratory diseases, including asthma, bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, moderate or severe obstructive sleep apnea (OSA), pulmonary embolism, pulmonary edema, lung cancer, or upper respiratory tract infection, etc.; * Coagulation disorders, tendency for oral/nasal bleeding, mucosal injury, or space-occupying lesions; * Severe cardiac insufficiency (≤4 MetS); * Severe renal insufficiency (acute kidney injury \[AKI\] or chronic kidney disease \[CKD\] stage 4 or higher); * Severe hepatic insufficiency (Child-Pugh class C or worse); * Planned therapeutic endoscopy (e.g., polypectomy, endoscopic mucosal resection \[EMR\], or other therapeutic procedures); * Pregnancy or breastfeeding; * Allergy to the study drugs; * Emergency surgery; * Daily alcohol intake ≥60 grams; * History of psychiatric disorders: e.g., depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease; * Myasthenia gravis; * Participation in other related clinical trials within the past 3 months; * Refusal to participate.

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Airway management Hypoxemia

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.