Status:
UNKNOWN
A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE OF THE ARCHIMEDES BIODEGRADABLE BILIARY AND PANCREATIC STENT
Lead Sponsor:
QualiMed Innovative Medizinprodukte GmbH
Conditions:
Obstructed Biliary and Pancreatic Duct
Eligibility:
All Genders
18+ years
Brief Summary
Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Sten...
Eligibility Criteria
Inclusion
- Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines
- Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted)
Exclusion
- Age \< 18 y
- Inability to understand the purpose of the study or refusal to cooperate
- Not available for routine follow-up visits
- Pregnancy
- Currently participating in a confounding trial before reaching first endpoint.
Key Trial Info
Start Date :
September 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT04708288
Start Date
September 22 2020
End Date
December 31 2023
Last Update
March 29 2023
Active Locations (8)
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1
HUS Helsinki University Hospital
Helsinki, Finland, 00290
2
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany, 40217
3
Emek Medical Center
Afula, Israel, 1834111
4
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089