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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03808272
Other study ID # E7148
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2019
Est. completion date October 30, 2021

Study information

Verified date November 2023
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date October 30, 2021
Est. primary completion date December 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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