AXIOS CHINA (E7148) | NCT03808272

NCT03808272

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System	Experimental	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System	Device: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System	Device	The HOT AXIOS Stent and Electrocautery- Enhanced Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with ≥ 70% fluid content.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Technical success rate	defined as: placement of the AXIOS stent using the Electrocautery Enhanced AXIOS delivery system and removal of the AXIOS stent using a standard method: such as endoscopic snare or forceps.	28± 7 days post stent placement
Clinical success rate	defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis	28± 7 days post stent placement

Eligibility Module

Eligibility Criteria

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.