- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03767166
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Milano
-
Rozzano, Milano, Italy, 20089
- Endoscopy Unit, Humanitas Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biodegradation time
Time Frame: 24 Months
|
24 Months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Biodegradable biliary and pancreatic stents placement
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Shanghai Zhongshan HospitalRenJi Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated... and other collaboratorsNot yet recruiting
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-
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-
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-
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