Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-26 @ 5:13 PM
Study NCT ID:
NCT03767166
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Archimedes Biodegradable Biliary and Pancreatic Stents
Sponsor:
Istituto Clinico Humanitas
Organization:
Study Overview
Official Title:
A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCHIMEDES
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: