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
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.
- 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