The Archimedes Biodegradable Biliary and Pancreatic Stents

Pancreatic Diseases Clinical Trial

— ARCHIMEDES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767166
• Other study ID #: 2275
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an indication to position one ore more biliary plastic stents during ERCP

• Patients with an indication to position a pancreatic plastic stent during ERCP

Exclusion Criteria:

• Age < 18 y

• Life expectancy < 1 m,

• Inability to pass a guidewire through stricture

• Contra-indication for endoscopy or interventional radiology

• Presence of partial gastric resection

• Unsigned informing consent form, ICF

• Pregnancy

• Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma

Related Conditions & MeSH terms

• Pancreatic Diseases

Intervention

Device:
• Biodegradable biliary and pancreatic stents placement
Biodegradable biliary and pancreatic stents placement

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodegradation time		24 Months