The Archimedes Biodegradable Biliary and Pancreatic Stents
NCT03767166 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30
Last updated 2021-03-18
Summary
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.
The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.
Conditions
Interventions
- DEVICE
-
Biodegradable biliary and pancreatic stents placement
Biodegradable biliary and pancreatic stents placement
Sponsors & Collaborators
-
Istituto Clinico Humanitas
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-01
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- Italy
Study Locations
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