Condition: Obstructed Biliary and Pancreatic Duct · Sponsor: QualiMed Innovative Medizinprodukte GmbH
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 aft…
This description comes directly from the study's public registry record.
NIta Gondaliya · +49 1716578285 · ngondaliya@q3medical.com
Manfred Guelcher · +4941716578200 · mguelcher@q3medical.com
Always discuss trial participation with your own doctor first.
| 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 |
| Evangelisches Krankenhaus Düsseldorf | Düsseldorf, Germany | Recruiting |
| Emek Medical Center | Afula, Israel | Completed |
| 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 |
| University Medical Center Ljubljana | Ljubljana, Slovenia | Recruiting |
| Hospital Universitario de Salamanca | Salamanca, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04708288