AXIOS CHINA (E7148)

Boston Scientific

Status

Completed

Conditions

Pancreatic Pseudocyst and Walled-off Necrosis

Treatments

Device: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03808272

E7148

Details and patient eligibility

About

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 population, to support the regulatory approval by CFDA

Enrollment

31 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

<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.