AXIOS CHINA (E7148)

Not Applicable

Completed

• Conditions: Pancreatic Pseudocyst and Walled-off Necrosis
• Interventions: Device: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

• Registration Number: NCT03808272
• Lead Sponsor: Boston Scientific Corporation

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 population, to support the regulatory approval by CFDA

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-17
• Study Start: 2019-04-17
• Primary Completion: 2020-12-24
• Study Completion: 2021-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System	HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

Primary Outcome Measures

Name	Time	Method
Technical success rate	28± 7 days post stent placement	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.
Clinical success rate	28± 7 days post stent placement	defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China