| 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-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 | 16.06.2022 | Study has ended | |||
| 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 | multicentric | C2 | Prof. Pierre Mégevand | Université de Genève |
Université de Genève, Genève Inselspital, Bern |
Commission Cantonale d'éthique de la recherche Genève (CCER) | Kantonale Ethikkommission Bern | 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 | PD 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. André Mermoud | 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-D0023 | MR42410: A PHASE IIIB, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED STUDY OF THE EFFECTIVENESS AND SAFETY OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB VS AFLIBERCEPT TR More ... | clinical trial | combination drugs/devices | multicentric | C2 | Prof. Dr. med. Christian Prünte | Roche Pharma (Schweiz) AG |
Universitätsspital Basel Augenklinik Klinik, 4056 Basel INSELSPITAL, Universitätsklinik für Augenheilkunde, Bern Fondation Asile Des Aveugles – Jules Gonin Eye Hospital, Hôpital ophtalmique Jules-Goni More ... |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Kantonale Ethikkommission Bern, Kantonale Ethikkommission Zürich | 26.09.2022 | Study has ended | |||
| 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 medidux™ bei PatientInnen mit HER2-positivem Brustkrebs während einer Chemotherapie in Kombination mit einer HER2-zielgerichteten Therapie (inklusive Tyro More ... | clinical trial | medical devices | multicentric | A1 | Prof. Dr. med. Andreas Trojan | Palleos healthcare GmbH |
See-Spital Horgen, 8810 Horgen Prolindo, Lindenhofspital, Bern Klinik für Gynäkologie, Onkologie, Hämatologie & Immun-therapie Medizini Onkologie Bellevue, Stadelhoferstrasse 42 Universitätsspital Z More ... |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Bern, 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 | Study has ended | ||||
| 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 | Study has ended | ||||
| 2022-D0014 | Non-invasive modulation of the human sensoriMOTor system using Transcranial Ultra-sound Stimulation in healthy and stroke participants | clinical trial | medical devices | monocentric | C2 | Prof Friedhelm C. Hummel | Ecole Polytechnique Fédérale de Lausanne (EPFL) |
EPFL, Geneva |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 02.11.2022 | |||||
| 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 | |||||
| 2022-D0012 | Cerebrospinal Fluid Drainage for traumatic Spinal Cord Injury | clinical trial | medical devices | monocentric | A2 | DR Juan Barges-Coll | CHUV |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 09.06.2022 | |||||
| 2022-D0011 | Einfluss von Verlängertem Tragen von Silikon-Hydrogel Kontaktlinsen auf die Hornhautsensibilität | clinical trial | medical devices | monocentric | A1 | Prof Daniela Nosch | Institut für Optometrie, FHNW |
Institut für Optometrie / FHNW, Olten |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 20.04.2022 | |||||
| 2022-D0010 | Evaluation of the impact of the skin type on healthy volunteers’ cerebral oxygenation measurements with the RheoPatch system, an exploratory single center prospective observational study. | clinical trial | medical devices | monocentric | A1 | Dr Roland Backhaus | Neurosono |
Neurosono, Zürich |
Kantonale Ethikkommission Zürich | 02.09.2022 | |||||
| 2022-D0009 | Implantable Cardiac Monitor to Detect Atrial Fibrillation in Patients with MINOCA | clinical trial | medical devices | multicentric | A2 | Prof. Dr. Dr. Lorenz Räber | Insel Gruppe AG |
Insel Gruppe AG, Klinik für Kardiologie, Bern Universitätsspital Zürich, Department of Cardiology, University Heart Center |
Kantonale Ethikkommission Bern | Kantonale Ethikkommission Zürich | 27.04.2022 | ||||