The Archimedes Biodegradable Biliary and Pancreatic Stents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Biodegradable biliary and pancreatic stents placement

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No