AXIOS CHINA (E7148)

Launched by BOSTON SCIENTIFIC CORPORATION · Jan 16, 2019

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 years old(including 18 and 75 years old)
• • 2. Eligible for endoscopic intervention
• • 3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
• • 4. 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
• • 5. Patient understands the study requirements and the treatment procedures and provides written Informed Consent.
• • 6. Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post CT imaging study.
• Exclusion Criteria:
• • 1. \<18 or \>75 years of age
• • 2. pseudocysts or walled-off necrosis which require nasocystic drainage,or\<6cm in maximum diameter, or walled-off necrosis \< 70% fluid content
• • 3. The fluid collection to be drained is an immature pseudocyst
• • 4. The fluid collection to be drained is a cystic neoplasm
• • 5. The fluid collection to be drained is a pseudoaneurysm
• • 6. The fluid collection to be drained is a duplication cyst
• • 7. The fluid collection to be drained is a non-inflammatory fluid collection
• • 8. There is more than one pseudocyst requiring drainage
• • 9. Abnormal coagulation: INR \> 1.5 and not correctable presence of a bleeding disorder; platelets \< 50,000/mm3
• • 10. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
• • 11. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
• • 12. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
• • 13. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
• • 14. 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.