The Archimedes Biodegradable Biliary and Pancreatic Stents

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.

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Key information

Conditions

Pancreatic Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biodegradable biliary and pancreatic stents placement

Device

Biodegradable biliary and pancreatic stents placement

Primary outcomes

Biodegradation time

Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: ARCHIMEDES

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 6, 2018
Registry last updated: Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed