The Archimedes Biodegradable Biliary and Pancreatic Stents
ARCHIMEDES
A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 18, 2021
March 1, 2021
1.9 years
November 20, 2018
March 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Biodegradation time
24 Months
Interventions
Biodegradable biliary and pancreatic stents placement
Eligibility Criteria
Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, 20089, Italy
Related Publications (1)
Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, Cappello A, Mangiavillano B, Omodei P, Preatoni P, Galtieri PA, Pellegatta G, Repici A. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411. doi: 10.1016/j.gie.2020.02.049. Epub 2020 Mar 5.
PMID: 32145287DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2018
First Posted
December 6, 2018
Study Start
February 1, 2019
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
March 18, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share