NCT03767166

The Archimedes Biodegradable Biliary and Pancreatic Stents

A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

• Pancreatic Diseases

Interventions

Type	Name	Description
DEVICE	Biodegradable biliary and pancreatic stents placement	Biodegradable biliary and pancreatic stents placement

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-12-06
• Last updated: 2021-03-18

Locations

1 site across 1 country: Italy