AXIOS Stent With Electrocautery Enhanced Delivery System

Launched by XLUMENA, INC. · May 20, 2014

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 and 75 years old, male or female
• • 2. Eligible for endoscopic intervention
• • 3. Acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage
• 4. Symptomatic pancreatic pseudocyst having the following characteristics:
• • Greater or equal to 6 cm in diameter (based upon the maximum cross-sectional area in the CT scan or transabdominal ultrasound).
• • Adherent to bowel wall, and
• • ≥70% fluid content
• • 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. The fluid collection to be drained is an immature pseudocyst
• • 2. The fluid collection to be drained is a cystic neoplasm
• • 3. The fluid collection to be drained is a pseudoaneurysm
• • 4. The fluid collection to be drained is a duplication cyst
• • 5. The fluid collection to be drained is a non-inflammatory fluid collection
• • 6. There is more than one pseudocyst requiring drainage
• 7. Abnormal coagulation:
• • INR \> 1.5 and not correctable
• • presence of a bleeding disorder
• • platelets \< 50,000/mm3
• • 8. Altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis).
• • 9. Intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound)
• • 10. Any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient.
• • 11. Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
• • 12. 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.