| BASEC ID | Project title | Type of project | Type of clinical trial | Study phase (clinical trials only) | multi- / monocentric | Category | Principal investigator | Sponsor | Investigational sites | Lead EC | Local EC(s) | Approval date | Minors | Study Ended | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-D0029 | SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med Thomas Pilgrim | Medtronic Bakken Research Center B.V. |
Insel Gruppe AG, Inselspital, Bern |
Kantonale Ethikkommission Bern | 23.11.2021 | |||||
| 2021-D0027 |
YpsoPump occlusion detection algorithm: Collection of real-world data for in-silico evaluation of a new software algorithm to refine occlusion detection in subjects with type 1 diabetes using contin More ... |
clinical trial | medical devices | monocentric | A1 | Prof. med. Markus Laimer | YPSOMED AG |
UDEM, Bern |
Kantonale Ethikkommission Bern | 21.12.2021 | Study has ended | ||||
| 2021-D0026 |
Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting (DEFINE GPS) |
clinical trial | medical devices | monocentric | A2 | Dr. Juan Fernando Iglesias | Philips Image Guided Therapy Devices |
Hôpitaux universitaires de Genève, Cardiology Unit, Genève |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 09.02.2022 | |||||
| 2021-D0025 | Epidural Electrical Stimulation to restore hemodynamic stability and trunk control in people with spinal cord injury. | clinical trial | medical devices | monocentric | C2 | Prof. Dr Jocelyne Bloch | Ecole Polytechnique Federale de Lausanne (EPFL) |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 29.11.2021 | |||||
| 2021-D0024 | CorPath GRX Neuro Study Protocol: An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms | clinical trial | medical devices | monocentric | A1 | PD Dr. med. Pasquale Mordasini | Corindus, Inc. (A Siemens Healthineers Company) |
Inselspital, Bern |
Kantonale Ethikkommission Bern | 08.11.2021 | |||||
| 2021-D0023 | GR40549: A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGEN More ... | clinical trial | combination drugs/devices | multicentric | C2 | Prof. Dr. med. Matthias Becker | Roche Pharma (Schweiz) AG |
Triemlispital, Zürich INSELSPITAL, Universitätsklinik für Augenheilkunde, Bern Vista Klinik Binningen, Hauptstrasse 55 Augenklinik - Universitaetsspital Basel, Mittlere Str. 55 Fondation Asile Des Ave More ... |
Kantonale Ethikkommission Zürich | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Kantonale Ethikkommission Bern, Ethikkommission Nordwest- und Zentralschweiz EKNZ | 12.11.2021 | ||||
| 2021-D0022 | LUNAR: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields) concurrent with standard of care therapies for treatment of stage 4 non-small cell lung cancer (NSCLC) following platin More ... | clinical trial | medical devices | monocentric | C1 | Prof. Dr. med. Miklos Pless | Novocure GmbH |
Kantonsspital Winterthur, Winterthur |
Kantonale Ethikkommission Zürich | 16.11.2021 | |||||
| 2021-D0021 | Prospective randomized controlled trial in patients with early to mid-stage medial knee osteoarthritis comparing clinical and biomechanical outcomes of foot deformity correcting insoles and lateral we More ... | clinical trial | medical devices | monocentric | A1 | Prof. Dr. Dr. med. Frank Klenke | Inselspital, Bern University Hospital |
Inselspital, Bern University Hospital, Bern |
Kantonale Ethikkommission Bern | 15.11.2021 | |||||
| 2021-D0020 | Augmented reality enhanced ultrasound-guided versus standard ultrasound or fluoroscopic injections | clinical trial | medical devices | monocentric | A1 | PD Dr. med. Nadja Farshad | Universitätsklinik Balgrist |
Balgrist University Hospital, Zürich |
Kantonale Ethikkommission Zürich | 18.03.2022 | |||||
| 2021-D0018 | Measuring the pharmacodynamics on cortical excitability using transcranial magnetic stimulations | clinical trial | medical devices | monocentric | A1 | Dr. Med. Maxime Baud | Inselspital |
Inselspital, Bern |
Kantonale Ethikkommission Bern | 10.11.2021 | |||||
| 2021-D0017 | Multicentric, prospective, comparative trial to assess the efficacy and safety of an anatomic total shoulder system. | clinical trial | medical devices | multicentric | C2 | Prof Dr. med Matthias Zumstein | Medacta International SA |
Lindenhofgruppe AG, Bern Klinik für Orthopädische Chirurgie und Traumatologie des Bewegungsapparates, Kantonsspital St.Gallen Rorschacher Strasse 95 |
Kantonale Ethikkommission Bern | Ethikkommission Ostschweiz (EKOS) | 28.10.2021 | ||||
| 2021-D0016 | Clinical evaluation of a new dental glass ceramic in the indirect restorative therapy (one arm study) | clinical trial | medical devices | monocentric | A1 | Dr. med. dent. Ming Hu | Ivoclar Vivadent AG |
Interne Klinik, Ivoclar Vivadent AG, Schaan |
Kantonale Ethikkommission Zürich | 14.09.2021 | Study has ended | ||||
| 2021-D0014 | A comparative clinical investigation of musician's Preference between a General listening program and a new music rationale for Hearing aids. | clinical trial | medical devices | monocentric | A1 | Dr. Barbara Simon | Bernafon AG |
Bernafon AG, Bern |
Kantonale Ethikkommission Bern | 24.08.2021 | Study has ended | ||||
| 2021-D0013 | A Prospective, Multi-center, Randomized Controlled Study to Evaluate the Safety and Efficacy of ARCR augmented with REGENETEN™ Bioinductive Implant System in Full thickness Tears (large or massive) Re More ... | clinical trial | medical devices | multicentric | A1 | Prof. Dr. Markus Scheibel | Smith & Nephew |
Schulthess Klinik, Zürich Balgrist University Hospital, University of Zurich Forchstrasse 340 |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Zürich | 27.07.2021 | ||||
| 2021-D0012 | Hyperbaric chamber program for wound healing prophylaxis in neurosurgery | clinical trial | medical devices | monocentric | A1 | Doctor Gildas Patet | HUG |
HUG, Geneva |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 05.10.2021 | |||||
| 2021-D0011 | Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator (REALITY) | clinical trial | medical devices | monocentric | A1 | Dr. Claude Haller | Abbott |
Hôpital du Valais, Sion |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 25.10.2021 | |||||
| 2021-D0010 | WAVE Global: The WavelinQTM Arterio-Venous Endovascular Fistula: A Global, Multi-Center, Prospective, Post-Market, Confirmatory, Interventional, Investigation. | clinical trial | medical devices | monocentric | A1 | Prof. Dr. Christoph Andreas Binkert | Bard Peripheral Vascular, Inc.(BD Peripheral Intervention) |
Institute of Radiology and Nuclear Medicine, Kantonsspital Winterthur, Winterthur |
Kantonale Ethikkommission Zürich | 10.08.2021 | Study has ended | ||||
| 2021-D0009 |
GLYPALCARE STUDY - Multicenter, randomized study for evaluating Continuous Glucose Monitoring (CGM) by using FreeStyle Libre 2 (FSL2) for preventing hyperglycemia/hypoglycemia crisis in advanced on More ... |
clinical trial | medical devices | monocentric | A1 | Dr Marta Mazzoli | Fondazione Antea |
Hospiz im Park, Arlesheim |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 10.08.2021 | |||||
| 2021-D0007 |
Evaluation of the acute safety and device success of the RISE SC coronary balloon dilatation catheter when used as a dilatation device in the stenotic portion of a coronary artery or bypass graft in More ... |
clinical trial | medical devices | multicentric | C2 | Prof. Marco Roffi | Biosensors Europe S.A. |
Geneva University Hospital, Geneva Centre Hospitalier Universitaire Vaudois, BH – 16 Service de Cardiologie Rue du Bugnon 46 Centre Hospitalier du Valais Romand - Site Sion, Service de cardiologie, More ... |
Commission Cantonale d'éthique de la recherche Genève (CCER) | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 25.11.2021 | ||||
| 2021-D0006 | Diabetes in Pregnancy Project und Mobile Health in Gestational Diabetes: An open label randomized controlled trial on the utility of continuous glucose monitoring in the care of gestational diabetes v More ... | clinical trial | medical devices | monocentric | A1 | Dr. med. Sofia Amylidi-Mohr | University Hospital |
Inselspital, University Hospital of Bern, Bern |
Kantonale Ethikkommission Bern | 20.07.2021 | |||||