NCT07012772 COMBO Endoscopy Oropharyngeal Airway in Sedated Endoscopic Retrograde Cholangiopancreatography for Patients
| NCT ID | NCT07012772 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang University |
| Condition | Choledocholithiasis With Cholecystitis With Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-06-12 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 , 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: 1. Patients with coagulation disorders, tendency for oral/nasal bleeding, mucosal injury/occupying lesions, or difficult oropharyngeal airway insertion making airway management unfeasible; 2. Severe cardiac dysfunction (\<4 METs); 3. Severe renal insufficiency (requiring preoperative dialysis); 4. Child-Pugh class C; 5. Diagnosed chronic obstructive pulmonary disease (COPD) or other acute/chronic pulmonary diseases requiring long-term/intermittent oxygen therapy; 6. Increased intracranial pressure; 7. Upper respiratory tract infections (oral/nasal/pharyngeal); 8. Fever (core temperature \>37.5°C); 9. Confirmed pregnancy or current breastfeeding; 10. Allergy to sedatives (e.g., propofol) or medical adhesives; 11. Emergency procedures; 12. Multiple trauma injuries; 13. Peripheral oxygen saturation (SpO2) levels below 95% while breathing room air preoperatively; 14. BMI \<18.5 or \>30 kg/m²; 15. Current participation in other clinical trials; 16. Other conditions deemed ineligible by investigators.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07012772 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Choledocholithiasis With Cholecystitis With Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07012772 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07012772 currently recruiting?
Yes, NCT07012772 is actively recruiting participants. Contact the research team at 184872238@qq.com for enrollment information.
Where is the NCT07012772 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China.
Who is sponsoring the NCT07012772 clinical trial?
NCT07012772 is sponsored by Zhejiang University. The trial plans to enroll 50 participants.