| 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-D0055 | Fine-scale mapping of brain anatomy and function with combined electroencephalography and 7T magnetic resonance imaging: a single-center study on healthy participants and on tremor, psychosis and epil More ... | clinical trial | medical devices | monocentric | C2 | Dr. João P. F. Jorge | CSEM |
Translational Imaging Center, SITEM-Insel, Bern |
Kantonale Ethikkommission Bern | 20.09.2022 | |||||
| 2022-D0053 | PEERLESS Study | clinical trial | medical devices | monocentric | A2 | Prof. Stefan Stortecky | Inari Medical |
Inselspital Bern, Bern |
Kantonale Ethikkommission Bern | 06.09.2022 | Study has ended | ||||
| 2022-D0052 | The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial – A randomized, multicenter, non-inferiority comparison of Shockwave Intravascular More ... | clinical trial | medical devices | multicentric | A1 | PD Matthias Bossard | Herzzentrum, LUKS |
Herzzentrum, LUKS, Luzern Service de cardiologie, Hopital Cantonal de Fribourg Chemin de Pensionnat |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 05.07.2022 | ||||
| 2022-D0051 | Cervical spinal cord stimulation in patients with cerebral vasospasm after subarachnoid haemorrhage: VasoStim study | clinical trial | medical devices | monocentric | C1 | Dr. med. Janine-Ai Schlaeppi | Universitätsklinik für Neurochirurgie |
Universitätsklinik für Neurochirurgie, Bern |
Kantonale Ethikkommission Bern | 11.11.2022 | |||||
| 2022-D0050 | The PROGRESS Trial - A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement | clinical trial | medical devices | multicentric | C1 | Prof. Dr. Markus Kasel | Edwards Lifesciences LLC |
Universitäres Herzzentrum, Zürich Unité de cardiologie structurelle, Département de Médicine Service de cardiologie R |
Kantonale Ethikkommission Zürich | Commission Cantonale d'éthique de la recherche Genève (CCER) | 25.11.2022 | ||||
| 2022-D0049 | Monocentric, Prospective Pilot Study to test the Efficacy and Safety of the FotonaSmooth Erbium:YAG Laser for the Treatment of Urethral Pain Syndrome in Women (Pilot UPS-IUL) | clinical trial | medical devices | monocentric | C1 | Prof. Dr. med. Volker Viereck | Kantonsspital Frauenfeld |
Kantonsspital Frauenfeld, Frauenfeld |
Ethikkommission Ostschweiz (EKOS) | 09.06.2022 | |||||
| 2022-D0048 |
Safety and performance of Vectorio® in conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up |
clinical trial | medical devices | monocentric | A1 | PD Rafael Duran | GUERBET |
Department of Diagnostic and InterventionalRadiology CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 16.09.2022 | Study has ended | ||||
| 2022-D0047 | The effect of increasing transcranial electric stimulation current or pulse duration on intraoperative patient movement and motor evoked potential amplitude | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med. Kathleen Seidel | Universitätsklinik für Neurochirurgie, Inselspital Bern |
Universitätsklinik für Neurochirurgie, Inselspital, Bern |
Kantonale Ethikkommission Bern | 22.08.2022 | Study has ended | ||||
| 2022-D0046 | Investigation of epileptic networks with transcranial alternate current stimulation (tACS). A randomised, parallel study. | clinical trial | medical devices | monocentric | A1 | PD Dr. med. Lukas Imbach | ETH Zurich |
Clinic Lengg, Zurich |
Kantonale Ethikkommission Zürich | 29.07.2022 | |||||
| 2022-D0045 | Additive versus subtractive manufactured interim implant- supported restorations in terms of clinical, aesthetic, patient-reported outcomes as well as cost- and time- efficiency: a randomized clinical More ... | clinical trial | medical devices | monocentric | A1 | PD Dr. med. dent. Alexis Ioannidis | Universität Zürich, Zentrum für Zahnmedizin |
Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Zürich |
Kantonale Ethikkommission Zürich | 15.07.2022 | |||||
| 2022-D0044 | ProSPective evaluation of the dIagnostic accuracy of siNe spiN non-contrast flat-dEtectoR CT (FDCT) for the detection of intracranial hemorrhage in Stroke patients - an open labelled, multicenter, non More ... | clinical trial | medical devices | multicentric | A2 | Prof. Marios-Nikos Psychogios | University Hospital Basel |
University Hospital Basel, Basel Inselspital Bern, Bern Kantonsspital Luzern, Sektion für Neuroradiologie |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Bern, Ethikkommission Nordwest- und Zentralschweiz EKNZ | 05.07.2022 | ||||
| 2022-D0043 | A pediatric, randomized controlled trial comparing two handheld devices (Evernoa and NObreath®) to measure fractional exhaled nitric oxide (FeNO) compared to the “gold-standard-technique” (ECO MEDICS More ... | clinical trial | medical devices | monocentric | A1 | Dr Leo Thanikkel | Kinderspital Zürich |
Kinderspital Zürich, Zürich |
Kantonale Ethikkommission Zürich | 19.08.2022 | yes | ||||
| 2022-D0042 | Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body Radiotherapy | clinical trial | medical devices | multicentric | A1 | Dr Jens Lustenberger | Boston Scientific Corporation |
University Hospital Basel, Basel Universitätsklinik für Radio-Onkologie, Inselspital, Bern |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Bern | 20.09.2022 | ||||
| 2022-D0041 | NON-INVASIVE SUBHARMONIC AIDED PRESSURE ESTIMATION (SHAPE) OF PORTAL HYPERTENSION | clinical trial | combination drugs/devices | monocentric | A2 | Prof. Annalisa Berzigotti | Insel Gruppe AG, Inselspital |
UVCM Hepatology, Bern |
Kantonale Ethikkommission Bern | 20.01.2023 | |||||
| 2022-D0040 | Intracranial hemodynamics with flow-sensitive 4D Magnetic Resonance Imaging at 7 Tesla | clinical trial | medical devices | monocentric | C2 | Prof. Dr. Bernd Jung | Inselgruppe AG |
Insegruppe AG, Bern |
Kantonale Ethikkommission Bern | 15.11.2022 | |||||
| 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 | Study has ended | ||||
| 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 | |||||