Status:
COMPLETED
AXIOS CHINA (E7148)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Pancreatic Pseudocyst and Walled-off Necrosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To study the safety and effectiveness of the AXIOS Stent with Electrocautery Enhanced Delivery System for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in Chinese ...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years old(including 18 and 75 years old)
- Eligible for endoscopic intervention
- Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
- Diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall
- Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
- Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
Exclusion
- \<18 or \>75 years of age
- pseudocysts or walled-off necrosis which require nasocystic drainage,or\<6cm in maximum diameter, or walled-off necrosis \< 70% fluid content
- The fluid collection to be drained is an immature pseudocyst
- The fluid collection to be drained is a cystic neoplasm
- The fluid collection to be drained is a pseudoaneurysm
- The fluid collection to be drained is a duplication cyst
- The fluid collection to be drained is a non-inflammatory fluid collection
- There is more than one pseudocyst requiring drainage
- Abnormal coagulation: INR \> 1.5 and not correctable presence of a bleeding disorder; platelets \< 50,000/mm3
- Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
- Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
- Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
- Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
- Currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Key Trial Info
Start Date :
April 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03808272
Start Date
April 17 2019
End Date
October 30 2021
Last Update
November 15 2023
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000