The Archimedes Biodegradable Biliary and Pancreatic Stents (ARCHIMEDES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03767166|
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : March 18, 2021
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|
|Pancreatic Diseases||Device: Biodegradable biliary and pancreatic stents placement|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement|
|Actual Study Start Date :||February 1, 2019|
|Actual Primary Completion Date :||December 31, 2020|
|Actual Study Completion Date :||December 31, 2020|
- Device: Biodegradable biliary and pancreatic stents placement
Biodegradable biliary and pancreatic stents placement
- Biodegradation time [ Time Frame: 24 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767166
|Endoscopy Unit, Humanitas Research Hospital|
|Rozzano, Milano, Italy, 20089|