Choledocholithiasis With Cholecystitis With ObstructionPhase 2NCT07012772
COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
A Phase 2 study testing The COMBO Endoscopy Oropharyngeal Airway in people with Choledocholithiasis With Cholecystitis With Obstruction and Obstructive Jaundice, run by Zhejiang University at 2 sites in China.
Trial summary
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis
- What is being tested?
- The COMBO Endoscopy Oropharyngeal Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jun 2025to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years；
- The ASA classification ranges from I to III.
- Patients have signed the informed consent form.
- Patients scheduled to undergo sedated ERCP examination;
- The estimated duration of the procedure does not exceed 45 minutes.
Who cannot join
- Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
- Severe cardiac dysfunction (<4 METs);
- Severe renal insufficiency (requiring preoperative dialysis);
- Child-Pugh class C;
- Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
- Increased intracranial pressure;
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- Upper respiratory tract infections (oral/nasal/pharyngeal);
- Fever (core temperature >37.5°C);
- Confirmed pregnancy or current breastfeeding;
- Allergy to sedatives (e.g., propofol) or medical adhesives;
- Emergency procedures;
- Multiple trauma injuries;
- Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively;
- BMI <18.5 or >30 kg/m²;
- Current participation in other clinical trials;
- Other conditions deemed ineligible by investigators.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
he First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
DiSan Diansan Su, PhD, 86+18616514088, 184872238@qq.com
- Recruiting
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.
- Conditions
- Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis, Cholelithiasis
- Being tested
- The COMBO Endoscopy Oropharyngeal Airway
- Keywords
- respiratory depression, The COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Sedation, ERCP
- Medical subject headings
- Jaundice, Obstructive, Pancreatitis, Cholelithiasis, Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The COMBO Endoscopy Oropharyngeal AirwayDevice
Using the COMBO Endoscopy Oropharyngeal Airway for oxygenation.
| Study group | Role | What they receive |
|---|---|---|
| The COMBO Endoscopy Oropharyngeal Airway Group | Experimental | In this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. Receives: Device: The COMBO Endoscopy Oropharyngeal Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypoxia
75% ≤ SpO2 < 90% for <60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Secondary outcomes (2)
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 < 95%
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s
Measured: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start12 Jun 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choledocholithiasis With Cholecystitis With ObstructionStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012772
- Sponsor's protocol ID
- ZJU2025B0632
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
- ClinicalTrials.gov ID
- NCT07012772
- Acronym / sponsor ID
- ZJU2025B0632
- Conditions
- Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice, Pancreatitis, Cholelithiasis
- Keywords
- respiratory depression, The COMBO Endoscopy Oropharyngeal Airway, Hypoxia, Sedation, ERCP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypoxia represents the prevailing adverse occurrence during the sedation of patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) with propofol. A recent innovation in this domain is the COMBO Endoscopy Oropharyngeal Airway-a multifaceted device that encompasses capnography monitoring, bite block , oxygenation support, and oropharyngeal airway management. This device has been purposefully designed to cater to the unique requirements of endoscopic procedures. The principal objective of this study is to assess the efficacy of the COMBO Endoscopy Oropharyngeal Airway in reducing the incidence of hypoxia in patients undergoing ERCP under sedation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The COMBO Endoscopy Oropharyngeal Airway Group | Experimental | Device: The COMBO Endoscopy Oropharyngeal AirwayIn this group, patients use the COMBO Endoscopy Oropharyngeal Airway for oxygenation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years；
- The ASA classification ranges from I to III.
- Patients have signed the informed consent form.
- Patients scheduled to undergo sedated ERCP examination;
- The estimated duration of the procedure does not exceed 45 minutes.
Key exclusion criteria (16 listed)
- Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible;
- Severe cardiac dysfunction (<4 METs);
- Severe renal insufficiency (requiring preoperative dialysis);
- Child-Pugh class C;
- Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy;
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 |
|---|---|---|
| The COMBO Endoscopy Oropharyngeal AirwayUsing the COMBO Endoscopy Oropharyngeal Airway for oxygenation. | Device | The COMBO Endoscopy Oropharyngeal Airway Group |
Primary outcome
The incidence of hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
75% ≤ SpO2 < 90% for <60 s
2 secondary outcomes
The incidence of sub-clinical respiratory depression
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
The incidence of severe hypoxia
Time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Feasibility and Safety of Supraglottic Oxygen Delivery Via an Endotracheal Tube for Non-intubated ERCP Anesthesia: A Two-Stage Phase II Clinical 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The COMBO Endoscopy Oropharyngeal Airway in people with Choledocholithiasis With Cholecystitis With Obstruction and Obstructive Jaundice, run by Zhejiang University at 2 sites in China.
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 5 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DiSan Head of Anesthesiology, PhD (86+18616514088, 184872238@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypoxia (time frame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025.