NCT03767166CompletedNot Applicable
A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement
Istituto Clinico Humanitas1 site in 1 country30 target enrollmentStarted: February 1, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Biodegradation time
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Biodegradation time
Time Frame: 24 Months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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