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 (AM GI Registry)

Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Stents are typically made from polymeric materials including Polylactic Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG), Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g., lactic acid, which is removed from the body by normal metabolic pathways. In the field of gastroenterology, these stents were first introduced in patients with an esophageal stenosis with encouraging results, although esophageal hyperplasia was a frequently encountered complication.

For biliary applications, biodegradable stents have been evaluated in several in-vitro and animal studies that demonstrated that the stents were safe and well tolerated. These stents provided an adequate radial force and resulted in complete stricture resolution within several months. The stents did not show any signs of biliary hyperplasia or integration in the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the outer layer sloughs during the degradation process similarly to the exfoliation of human skin. Also, the stent could be removed from the bile duct, thus offering the possibility of extraction if necessary at various times after implantation.

In 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication encountered and during the two years of follow-up, the bile duct remained patent.

Later, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a polydioxanone biodegradable biliary stent. The results have been published in the Journal of the European Society of Radiology. The authors concluded that percutaneous placement of a biodegradable biliary stent is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period.

Prior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational study which has completed enrolment with 53 patients included, and the results are not yet published. In this study approximately half the stents were deployed in the bile duct (53%) and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer have the study device. No patient remains in the study with a stent in place during the time of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin was reduced by 25.6%, which exceeded the >20% clinical success criterion, quality of life score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and technical success was achieved in all 53 patients.

Data from the ARCHIMEDES Investigational study was used for CE Mark approval, which was obtained in June 2018.

Study Overview

• Status: Recruiting
• Conditions: Obstructed Biliary and Pancreatic Duct
• Intervention / Treatment: Device: ARCHIMEDES Biodegradable Biliary and Pancreatic Stent

• Study Type: Observational
• Enrollment (Anticipated): 198

Contacts and Locations

• Study Contact: Name: Volker Wenke, MSc; Phone Number: +49 173 7211332; Email: wenke@qualimed.de
• Study Contact Backup: Name: Manfred Guelcher, MSc; Phone Number: +4941716578200; Email: guelcher@qualimed.de

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • HUS Helsinki University Hospital
    • Contact: Leena Kylänpää, MD; Email: leena.kylanpaa@hus.fi
    • Contact: Heidi Asmundela, MD; Email: ext-heidi.asmundela@hus.fi
• Germany
  • Düsseldorf, Germany, 40217
    • Recruiting
    • Evangelisches Krankenhaus Düsseldorf
    • Contact: Biljana Dimitrijevic, PhD; Phone Number: +49 (0)211919483 601; Email: Biljana.Dimitrijevic@evk-duesseldorf.de
    • Contact: Thomas Veiser, MD; Email: thomas.veiser@evk-duesseldorf.de
• Israel
  • Afula, Israel, 1834111
    • Recruiting
    • Emek Medical Center
    • Contact: Ian M. Gralnek, MD; Phone Number: +972046495545; Email: ian_gr@clalit.org.il
    • Contact: Inbal Lasry Reish, PhD; Phone Number: +9720528877977; Email: inbal_la@clalit.org.il
• Italy
  • Forlì, Italy, 47121
    • Recruiting
    • AUSL Romagna Ospedale Morgagni - Pierantoni
    • Contact: Carlo Fabbri, MD; Email: carlo.fabbri@auslromagna.it
    • Contact: Cecilia Binda, MD; Email: cecilia.binda@gmail.com
  • Roma, Italy, 00128
    • Recruiting
    • UCBM - Campus Bio-Medico University
    • Contact: Francesco Di Matteo, MD; Email: m.martino@policlinicocampus.it
    • Contact: Maria Gulia Nigro, MD; Phone Number: +3906225418058; Email: Ma.nigro@policlinicocampus.it
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Endoscopy Unit, Humanitas Research Hospital
      • Principal Investigator: Andrea Anderloni, MD
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Not yet recruiting
    • University Medical Center Ljubljana
    • Contact: Samo Plut, MD; Email: samo.plut@kclj.si
    • Contact: Dr. Martina Jaklič, MD; Email: martina.jaklic@kclj.si
• Spain
  • Salamanca, Spain, 37007
    • Recruiting
    • Hospital Universitario de Salamanca
    • Contact: Alberto Álvarez Delgado, MD; Phone Number: +34 696351845; Email: aalvarezd@saludcastillayleon.es
    • Contact: ALEJANDRO NUÑEZ Alonso, PhD; Phone Number: 55400 +34 923291100; Email: alnual@saludcastillayleon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that will respect the inlcusion criteria will be enrolled in the study.

Description

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.

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	Measure Description	Time Frame
Safety data of the procedure	Number of patients with adverse events	24 months
Clinical performance of the procedure	Number of patients with better synthomatology	24 months

Collaborators and Investigators

• Sponsor: QualiMed Innovative Medizinprodukte GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No