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
2022-D0042 Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body Radiotherapy clinical trial medical devices monocentric A1 Dr Jens Lustenberger Boston Scientific Corporation University Hospital Basel, Basel
Ethikkommission Nordwest- und Zentralschweiz EKNZ 20.09.2022
2022-D0039 Evolut™ EXPAND TAVR II Pivotal Trial clinical trial medical devices monocentric C1 Prof. Thomas Pilgrim Medtronic Bakken Research Center Inselspital, Universitätsspital Bern, Bern
Kantonale Ethikkommission Bern 22.08.2022
2022-D0038 Assessing the clinical acceptability of ultra-low dose PET/CT and CT-less PET using a long axial field-of-view PET/CT system: a single-centre, single-blinded method agreement study clinical trial medical devices monocentric A2 Prof. A Rominger Inselspital Inselspital, Bern
Kantonale Ethikkommission Bern 02.08.2022
2022-D0037 Assessment of image quality and biomarkers of Multispectral Optoacoustic Tomography (MSOT) in physiological and pathophysiological soft tissue clinical trial medical devices monocentric A1 Andreas Boss University Hospital Zurich USZ, Zürich
Kantonale Ethikkommission Zürich 06.05.2022
2022-D0036 Randomized Controlled Trial on the Efficacy of a Transdiagnostic Online-Prevention Approach in Adolescents (EMPATIA) clinical trial medical devices monocentric C2 Prof. Dr. phil. Stefanie J. Schmidt University of Bern Department of Clinical Child and Adolescent Psychology, University of Bern, Bern
Kantonale Ethikkommission Bern 22.06.2022 yes
2022-D0035 Bernese Intracranial Stenosis Study clinical trial medical devices monocentric A2 PD Dr. med. MSc Mirjam Heldner Insel Gruppe University and University Hospital Bern, Bern
Kantonale Ethikkommission Bern 21.04.2022
2022-D0034 Fully closed-loop insulin delivery in abdominal surgery: a randomised controlled two-centre trial (CLAB-Study) clinical trial medical devices multicentric A1 Prof. Lia Bally Inselspital, Bern University Hospital, University of Bern Inselspital Bern, University Hospital Bern and University of Bern, Bern
University Hospital Basel, Anaesthesiology
Spitalstrasse 21
Kantonale Ethikkommission Bern Ethikkommission Nordwest- und Zentralschweiz EKNZ 08.07.2022
2022-D0033 Hybrid micro-macro electrodes to record the activity of single neurons during seizures in patients who suffer from epilepsy clinical trial medical devices monocentric C2 Prof. Pierre Mégevand Université de Genève Université de Genève, Genève
Commission Cantonale d'éthique de la recherche Genève (CCER) 28.06.2022
2022-D0030 Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Affixus Natural Nail System Humeral Nail (Implants and Instrumentation) clinical trial medical devices monocentric A1 PD. Dr. med. Florian Hess Zimmer Biomet Kantonsspital Frauenfeld, Frauenfeld
Ethikkommission Ostschweiz (EKOS) 07.07.2022
2022-D0029 Burst-Deep Brain Stimulation of the thalamus for Neuropathic Facial Pain and Central Poststroke Pain: a prospective, randomized cross-over feasibility trial clinical trial medical devices monocentric C1 Dr. med. Andreas Nowacki Universitätsklinik für Neurochirurgie Universitätsklinik für Neurochirurgie, Bern
Kantonale Ethikkommission Bern 02.08.2022
2022-D0028 A PROSPECTIVE, MULTICENTER MASKED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE MINIJECT CS627 IMPLANT IN SUBJECTS WITH OPEN ANGLE GLAUCOMA clinical trial medical devices monocentric C2 Dr. Kaweh Mansouri iSTAR Medical Glaucoma Center, Lausanne
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) 13.09.2022
2022-D0025 Clinical validation of BoneMRI in the spine clinical trial medical devices monocentric C1 PD Dr. Martin N. Stienen MRIguidance Kantonsspital St. Gallen, St. Gallen
Ethikkommission Ostschweiz (EKOS) 07.04.2022
2022-D0024 Single Shot Pulmonary Vein Isolation: Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation
– A Multi-Center Non-Inferiority Design Clinical More ...
clinical trial medical devices multicentric A2 Prof. Dr. Tobias Reichlin Universitätsklinik für Kardiologie Inselspital, Universitätsspital Bern, Bern
University Hospital Basel, Department of Cardiology
Kantonale Ethikkommission Bern Ethikkommission Nordwest- und Zentralschweiz EKNZ 30.06.2022
2022-D0022 Clinical validation of CPM#1 compression ratio measurement on healthy volunteers clinical trial medical devices monocentric C2 Dr Helen Anwander Compremium AG Inselspital Bern, Bern
Kantonale Ethikkommission Bern 02.05.2022 Study has ended
2022-D0021 Evaluation der digitalen Gesundheitsanwendung consilium care™ bei Patienten mit HER2-positivem Brustkrebs während einer Chemotherapie in Kombination mit einer HER2-zielgerichteten Antikörper-Therapie: More ... clinical trial medical devices multicentric A1 Prof. Dr. med. Andreas Trojan Palleos healthcare GmbH OnkoZentrum Zürich, 8038 Zürich
Klinik für Gynäkologie, Onkologie, Hämatologie & Immun-therapie
Medizini
Onkologie Bellevue, Stadelhoferstrasse 42
Kantonale Ethikkommission Zürich Kantonale Ethikkommission Zürich, Ethikkommission Nordwest- und Zentralschweiz EKNZ 14.06.2022
2022-D0020 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia clinical trial medical devices multicentric A1 Dr. Benjamin Berte University Hospital (CHU) of Bordeaux Luzerner Kantonsspital, Luzerner
Inselspital Bern, Bern
Centre Hospitalier Universitaire Vaudois, Unité des troubles du rythme, service de cardiolog
Ethikkommission Nordwest- und Zentralschweiz EKNZ Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Kantonale Ethikkommission Bern 16.06.2022
2022-D0018 Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System clinical trial medical devices monocentric C2 PD Dr. med. Ronny R. Büchel GE Healthcare University Hospital Zurich, Zurich
Kantonale Ethikkommission Zürich 03.05.2022
2022-D0017 Prospective, multicentre single-arm Post-Market Clinical Follow-up (PMCF) study to evaluate safety and
performance of the BeYond Venous Self-Expanding Stent
clinical trial medical devices monocentric A1 Dr. Stefano Barco Bentley InnoMed gmbH Universitätsspital Zürich, Klinik für Angiologie, Zürich
Kantonale Ethikkommission Zürich 01.07.2022
2022-D0016 Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions via Transradial Access clinical trial medical devices monocentric C2 Prof. Dr. med. / Christoph / Binkert Cordis US Corp. Kantonsspital Winterthur, Winterthur
Kantonale Ethikkommission Zürich 21.06.2022
2022-D0013 A premarket clinical investigation study on the 3-cycle performance and safety of the non-hormonal, wearable sensor-based, digital contraceptive device, Ava Prevent clinical trial medical devices monocentric C2 Prof. Dr. Brigitte Leeners Ava Sciences - FMTC GmbH University Hospital Zürich, Zürich
Kantonale Ethikkommission Zürich 21.06.2022