| 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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-D0059 | Sensitivity and specificity study of electromedical device Nexkin DSPT and manual measurement of hives in allergy skin prick tests | clinical trial | medical devices | monocentric | A1 | PD Dr. Lukas Jörg | Inselspital Bern |
Inselspital, Bern |
Kantonale Ethikkommission Bern | 08.08.2024 | |||||
| 2024-D0058 | A blinded randomized clinical investigation of RefluxStop™ compared with Nissen fundoplication in the treatment of Gastroesophageal Reflux Disease (GERD). | clinical trial | medical devices | monocentric | A1 | Dr. med, Professor (USC) Jörg Zehetner | Implantica CE Reflux Ltd |
Klinik Beau-Site Hirslanden Bern, Swiss1Chirurgie AG, Bern |
Kantonale Ethikkommission Bern | 26.08.2024 | |||||
| 2024-D0057 | JACCS - Cytokine adsorption during complex cardiac surgery: the JACCS Controlled Randomized Clinical Trial. | clinical trial | medical devices | monocentric | A1 | Dr Antoine Schneider | CHUV |
CHUV -SMIA, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 20.08.2024 | |||||
| 2024-D0055 | Evaluation of neuro-muscular monitoring using the TetraGraph device | clinical trial | medical devices | monocentric | A1 | Prof. Dr. Alexander Dullenkopf | Spital Thurgau Frauenfeld |
Spital Thurgau Frauenfeld, Frauenfeld |
Ethikkommission Ostschweiz (EKOS) | 13.06.2024 | |||||
| 2024-D0054 | CLARITY-Gastric01 - A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared with Investigator’s Choice of Therapy in Second- or Later-Line Adult Partici More ... | clinical trial | in vitro diagnostic medical devices | multicentric | C2 | Dr med Alexander Siebenhüner | AstraZeneca |
Klinik für Hämatologie und Onkologie Hirslanden Zürich AG , Witellikerstrasse 40, 8032 Zürich INSELSPITAL Universitätsspital Bern Universitätsklinik für medizinische Onkologie Klinische Forschungseinh More ... |
Kantonale Ethikkommission Zürich | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Kantonale Ethikkommission Bern, Kantonale Ethikkommission Zürich | 27.08.2024 | ||||
| 2024-D0051 | HYsterectomy with adnexal surgery Procedures with the DEXTER Robotic system | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med. Michael Mueller | Distalmotion SA |
Inselspital Bern, Bern |
Kantonale Ethikkommission Bern | 31.07.2024 | |||||
| 2024-D0049 | Comparing prostate cancer screening between standardized 3T MRI screening protocol and Low-Field MRI in a prospective study | clinical trial | medical devices | monocentric | A1 | Dre Naïk Vietti Violi | Lausanne University Hospital |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 27.06.2024 | |||||
| 2024-D0047 | Sentinel lymph node detection in cutaneous melanoma: a prospective diagnostic accuracy study of indocyanine green-based near-infrared fluorescence imaging alone versus lymphoscintigraphy | clinical trial | medical devices | monocentric | A1 | PD Dr med Ioana Lese | Inselspital, University Hospital Bern |
Plastic and Hand Surgery, Inselspital, University Hospital Bern, Bern |
Kantonale Ethikkommission Bern | 26.08.2024 | |||||
| 2024-D0046 | Value of advanced MRI techniques in the assessment of endometriosis | clinical trial | medical devices | monocentric | A1 | PD Dr. A. Hötker | University Hospital Zurich |
University Hospital Zurich, Zurich |
Kantonale Ethikkommission Zürich | 18.06.2024 | |||||
| 2024-D0045 | Overnight treatment of subacute stroke patients with insomnia using vestibular stimulation from a rocking bed (Somnomat Casa) – A feasibility study | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Karsten Krakow | Sensory-Motor Systems Lab, IRIS, ETH Zurich |
Rehaklinik Zihlschlacht AG, 8588 Zihlschlacht |
Ethikkommission Ostschweiz (EKOS) | 27.06.2024 | |||||
| 2024-D0044 | Evaluation of correlations between volatile organic compounds (VOCs) spectra measured with GC-IMS and MOx-sensors and venous blood glucose in subjects with Type 2 Diabetes | clinical trial | in vitro diagnostic medical devices | monocentric | A2 | Prof. Dr. med. Markus Laimer | BOYDSense SAS |
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Bern |
Kantonale Ethikkommission Bern | 21.08.2024 | |||||
| 2024-D0043 | Single-center evaluation of Sleepiz One+ algorithms in estimating respiration rate and heart rate compared to gold standard | clinical trial | medical devices | monocentric | A1 | Dr. med. Christian Neumann | Sleepiz AG |
Zentrum für Schlafmedizin ‘Schlaflabor Fluntern’, Zurich |
Kantonale Ethikkommission Zürich | 16.07.2024 | |||||
| 2024-D0041 | Artificial Intelligence assisted tracheal video intubation: an observational trial about correctness of Larynguide | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med. Thomas Riva | aiEndoscopic AG |
Inselspital - Universitätsspital Bern, Bern |
Kantonale Ethikkommission Bern | 30.05.2024 | |||||
| 2024-D0039 | Optimization of transcranial motor evoked potentials in supratentorial surgeries | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med. Kathleen Seidel | Neurosurgery department, Inselspital |
Neurosurgery department, Inselspital, Bern |
Kantonale Ethikkommission Bern | 27.06.2024 | |||||
| 2024-D0037 | The DEXTER-assisted non-emergent and acute cholecystectomy Study | clinical trial | medical devices | multicentric | A1 | Prof. Dr. med. Stefan Breitenstein | Distalmotion SA |
Kantonsspital Winterthur, Winterthur Hirslanden Zurich, Chirurgisches Zentrum Zürich Witellikerstrasse 40 |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Zürich | 14.06.2024 | ||||
| 2024-D0036 | A prospective, multinational, multicentre, open-label, randomised, non-inferiority trial to compare safety and effectiveness of Meril’s Myval Transcatheter Heart Valve (THV) series vs. Contemporary Va More ... | clinical trial | medical devices | monocentric | A1 | PD Dr. med. / Thomas / Nestelberger | Meril Life Sciences Pvt. Ltd. |
Universitätsspital Basel, Universitäres Herzzentrum, Basel |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 16.05.2024 | |||||
| 2024-D0035 | 20210081_Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Me More ... | clinical trial | in vitro diagnostic medical devices | monocentric | C2 | Dr. med. Ralph Fritsch | AMGEN |
Universitätsspital Zürich, Zürich |
Kantonale Ethikkommission Zürich | 06.09.2024 | |||||
| 2024-D0034 | INCREASED PERI-IMPLANT BONE FORMATION AROUND SIMULTANEOUSLY GRAFTED HYDROPHILIC MICROROUGH TITANIUM IMPLANTS - AN EXPLORATORY HUMAN HISTOMETRIC ANALYSIS | clinical trial | combination drugs/devices | monocentric | A1 | Dr. Alexandre Perez | Hôpitaux Universitaires de Genève |
HUG, Genève |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 26.06.2024 | |||||
| 2024-D0028 | Telerehabilitation after a stroke: Feasibility, safety and performance evaluation of an application-based training programme for patients after a stroke in the subacute phase | clinical trial | medical devices | monocentric | C2 | PD Dr. Corina Schuster-Amft | Reha Rheinfelden |
Reha Rheinfelden, Rheinfelden |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 14.06.2024 | |||||
| 2024-D0027 | Volumetric dimensional changes after surgical pontic site development procedures with connective tissue graft or collagen matrix: A noninferiority randomized controlled trial | clinical trial | medical devices | monocentric | A1 | Dr. med. dent. Manrique Fonseca | Klinik für Rekonstruktive Zahnmedizin und Gerodontologie, Universität Bern |
Klinik für Rekonstruktive Zahnmedizin und Gerodontologie, Universität Bern, Bern |
Kantonale Ethikkommission Bern | 26.08.2024 | |||||