ARCHIMEDES: The Archimedes Biodegradable Biliary and Pancreatic Stents

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Completed

CT.gov ID

NCT03767166

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Diseases	Device: Biodegradable biliary and pancreatic stents placement

Study Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Biodegradation time [24 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

Istituto Clinico Humanitas

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Clinico Humanitas

ClinicalTrials.gov Identifier:

NCT03767166

Other Study ID Numbers:

2275

First Posted:

Dec 6, 2018

Last Update Posted:

Mar 18, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pancreatic Diseases

Study Results

No Results Posted as of Mar 18, 2021