Biodegradable Biliary and Pancreatic Stent: Safety and Performance Observation
Official title: A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE OF THE ARCHIMEDES BIODEGRADABLE BILIARY AND PANCREATIC STENT
Run by QualiMed Innovative Medizinprodukte GmbH · NCT04708288 · Data updated 2026-11-12
This observational study tests whether a biodegradable stent placed in the biliary or pancreatic duct is safe and works well enough in patients who need a stent.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 198 (estimated) |
| Sponsor | QualiMed Innovative Medizinprodukte GmbH Industry-sponsored |
| Locations | 11 sites (Helsinki and 10 other locations) |
| Status | Recruiting |
| Started | October 3, 2020 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT04708288 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) requiring a pancreatic or biliary stent placement who can comply with follow-up and provide informed consent.
✕Probably not a fit
Patients not likely to benefit include those not undergoing stent placement, unable to follow up, or with conditions contraindicating stent use.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study observes the ARCHIMEDES biodegradable biliary and pancreatic stent in real-world patients requiring duct stents. It collects data on safety and clinical performance without randomization. The trial references prior use of similar materials in other medical fields and explores hydrolytic degradation and tolerability in the biliary and pancreatic ducts. It involves pre-specified eligibility criteria, informed consent, and routine follow-up to monitor outcomes. Sites include hospitals in Helsinki, Paris, and Düsseldorf under a single sponsor.
Why it matters
Potential benefit: If successful, patients could benefit from a stent that dissolves over time, potentially reducing need for a removal procedure.
How similar studies have gone: Prior work in other organs and early gastroenterology use of biodegradable stents showed safety but with some complications; this area has mixed but encouraging data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines * Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted) Exclusion Criteria: * Age \< 18 y * Inability to understand the purpose of the study or refusal to cooperate * Not available for routine follow-up visits * Pregnancy * Currently participating in a confounding trial before reaching first endpoint.
Where it's running
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Evangelisches Krankenhaus Düsseldorf
Düsseldorf, Germany Recruiting -
University Medical Center Ljubljana
Ljubljana, Slovenia Recruiting -
Hospital Universitario de Salamanca
Salamanca, Spain Recruiting -
HUS Helsinki University Hospital
Helsinki, Finland Completed -
Hôpital Européen Georges-Pompidou HEGP Service d'Hépato-gastro-entérologie et endoscopies digestives
Paris, France Active not recruiting -
Emek Medical Center
Afula, Israel Completed
Show 5 more locations
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Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy Active not recruiting -
AUSL Romagna Ospedale Morgagni - Pierantoni
Forlì, Italy Completed -
Gastroenterology and Digestive Endoscopy Unit Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, Italy Active not recruiting -
UCBM - Campus Bio-Medico University
Roma, Italy Active not recruiting -
Tan Tock Seng Hospital Pte Ltd,
Singapore, Singapore Completed
Study contacts
- Study coordinator: NIta Gondaliya
- Email: ngondaliya@q3medical.com
- Phone: +49 1716578285
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Biodegradable balloon-expandable biliary stent for benign and malignant bile duct strictures
A one-arm study tests a biodegradable, balloon-expandable stent to open narrowed bile ducts and see if it’s safe and works for people with biliary obstructions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.