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Clinical Trial Record

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AXIOS CHINA (E7148)

2019-04-17

2020-12-24

2021-10-30

31

Study Overview

AXIOS CHINA (E7148)

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

N/A

  • Pancreatic Pseudocyst and Walled-off Necrosis
  • DEVICE: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
  • E7148

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-01-16  

N/A  

2023-11-13  

2019-01-16  

N/A  

2023-11-15  

2019-01-17  

N/A  

2023-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

DEVICE: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System

  • 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 MeasuresMeasure DescriptionTime Frame
Technical success ratedefined 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 ratedefined as: at least a 50% decrease in pseudocyst's maximum diameter, based on radiographic analysis28± 7 days post stent placement
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Shutian Zhang, Beijing Friendship Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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