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AXIOS CHINA (E7148)

Primary Purpose

Pancreatic Pseudocyst and Walled-off Necrosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst and Walled-off Necrosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Friendship Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

Arm Description

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

Outcomes

Primary Outcome Measures

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.
Clinical success rate
defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis

Secondary Outcome Measures

Full Information

First Posted
January 16, 2019
Last Updated
February 23, 2022
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03808272
Brief Title
AXIOS CHINA (E7148)
Official Title
A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of AXIOS Stent and Electrocautery-enhanced Delivery System in Chinese Patients With Pancreatic Pseudocyst and Walled-off Necrosis(WON)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocyst and Walled-off Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Arm Type
Experimental
Arm Description
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Intervention Type
Device
Intervention Name(s)
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical success rate
Description
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.
Time Frame
28± 7 days post stent placement
Title
Clinical success rate
Description
defined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis
Time Frame
28± 7 days post stent placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiyu Zeng
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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AXIOS CHINA (E7148)

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