| 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 | |||||