New device aims to keep oxygen levels up during endoscopy in obese patients
NCT ID NCT06796764
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new device called the COMBO Endoscopy Oropharyngeal Airway in 580 obese patients undergoing sedated gastrointestinal endoscopy. The device combines oxygen delivery, breathing monitoring, and a bite block to prevent low oxygen levels. Researchers will compare it to a standard nasal cannula to see if it reduces the risk of hypoxia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- COMBO Endoscopy Oropharyngeal Airway (device)
- What this could lead to
- If it works, this device could reduce dangerous drops in oxygen levels during routine endoscopy in obese patients, making the procedure safer.
- What could go wrong
- This is a relatively small, early-stage trial testing a device, not a drug. The device may not work better than standard care, and results may not apply to all patients or settings.
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
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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
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About 580 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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≤ Age ≤70. * BMI ≥ 28 kg/m². * The ASA classification ranges from I to II. * Patients have signed the informed consent form. * Patients undergoing gastroendoscopy and colonoscopy procedure. * The estimated duration of the procedure does not exceed 45 minutes. Exclusion Criteria: * Patients who exhibit contraindications to oropharyngeal airway ventilation, such as coagulation disorders, a predisposition to oral and nasal bleeding, mucosal damage, or anatomical constraints impeding oropharyngeal channel placement. * Severe cardiac insufficiency, defined as a maximal exercise capacity of less than 4 metabolic equivalents (METs). * Profound renal insufficiency necessitating preoperative dialysis. * A confirmed severe liver dysfunction. * Patients diagnosed with chronic obstructive pulmonary disease (COPD) or those presently experiencing other acute and chronic pulmonary conditions necessitating prolonged or intermittent oxygen therapy. * Elevated intracranial pressure. * Upper respiratory tract infections, encompassing the oral, nasal, and pharyngeal regions. * Fever, defined as a core body temperature exceeding 37.5 degrees Celsius. * Pregnancy or lactation. * Hypersensitivity reactions to sedatives like propofol or medical equipment such as adhesive tape. * Urgent surgical intervention. * Polytrauma. * Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively. * BMI\<28 kg/m². * Patients with a documented history of substance abuse, specifically drugs and/or alcohol, within the two years preceding the commencement of the screening period. Substance abuse in this context is defined as consuming more than three standard alcoholic beverages daily, roughly equivalent to 10g of alcohol or 50g of Chinese Baijiu. * Patients with a history of mental and neurological disorders, including but not limited to depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, and myasthenia gravis. * Presently engaged in concurrent participation in additional clinical trials. * Patients considered ineligible by researchers for inclusion in this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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The Fourth Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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Zhejiang Cancer hospital
RECRUITINGHangzhou, Zhejiang, 310000, China
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