Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2019-04-17
2021-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Shutian Zhang
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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E7148
Identifier Type: -
Identifier Source: org_study_id
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