| 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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-D0096 |
BIO|MASTER.Amvia Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family |
clinical trial | medical devices | monocentric | A1 | Dr. Christian Grebmer | BIOTRONIK SE & Co. KG |
Luzerner Kantonsspital, Luzern |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 21.11.2023 | |||||
| 2023-D0076 | Navitor Post-Market Clinical Follow Up Study (VISTA Study) | clinical trial | medical devices | monocentric | A1 | Dr- Philipp Klaus Haager | Abbott |
Kantonsspital St.Gallen, St. Gallen |
Ethikkommission Ostschweiz (EKOS) | 07.09.2023 | |||||
| 2023-D0075 | Low-intensity Extracorporeal Shockwave Therapy with the NephrospecTM device for the treatment of Hypertension in patients diagnosed with Chronic Kidney Disease (CKD) with eGFR 20-60 ml/min/1.73m2 : a More ... | clinical trial | medical devices | monocentric | A1 | PD Dr Menno Pruijm | Centre hospitalier universitaire vaudois, CHUV |
Centre hospitalier universitaire vaudois, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 09.11.2023 | |||||
| 2023-D0072 | Safety and Performance of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease – Hexanium TLIF study | clinical trial | medical devices | monocentric | A1 | Doctor Frédéric Schils | SPINEVISION |
Clinique Générale Beaulieu, Geneve |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 21.11.2023 | |||||
| 2023-D0064 | A Pilot Study to Assess the Feasibility of a Novel Non-Invasive Technology to Measure Glucose Dynamics in Adults Living with Type 1 Diabetes Mellitus: A Single-Arm Pilot Study | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med Markus Laimer | Spiden AG |
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM), Inselspital, Universitätsspital, Bern |
Kantonale Ethikkommission Bern | 05.10.2023 | |||||
| 2023-D0057 |
VANTAGE Clinical Trial (Evaluation of TAVI Using the NAVITOR Valve in a Global Investigation) |
clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Maurizio | Abbott Medical |
Taramasso, Zürich |
Kantonale Ethikkommission Zürich | 01.12.2023 | |||||
| 2023-D0055 | Safety and normative data with neos™, in healthy volunteers, children and patient populations with ophthalmological or neurological disease | clinical trial | medical devices | monocentric | A1 | MD, PhD, Tatiana BREMOVA-ERTL | machineMD AG |
Neurology Inselspital Bern, Bern |
Kantonale Ethikkommission Bern | 27.09.2023 | yes | ||||
| 2023-D0054 | A Prospective, Single-Arm, Monocentric Pilot Study to Evaluate the Safety and Feasibility of Transcranial Alternate Current Stimulation with the Miamind Neurostimulator in Healthy Participants | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Raphael Guzman | Bottneuro AG |
University Hospital Basel, Basel |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 14.08.2023 | |||||
| 2023-D0051 | Monocentric, prospective, randomised, single blinded, active-controlled trial to prove that the treatment with Monalisa Glide is equal to topic Clobetasol propionate maintenance therapy in vulvar lich More ... | clinical trial | combination drugs/devices | monocentric | A1 | Dr.med. Rebecca Rachel Zachariah | Kantonsspital Winterthur |
Kantonsspital Winterthur, 8400 Winterthur |
Kantonale Ethikkommission Zürich | 26.09.2023 | |||||
| 2023-D0049 | Pre-market monocentric cross-sectional clinical investigation of MAIA on healthy subjects and patients with retinal pathology: agreement with MAIA 2013 EDITION microperimeter and repeatability evaluat More ... | clinical trial | medical devices | monocentric | C2 | PD Dr. med. Maximilian Pfau | Centervue |
Universitätsspital Basel, Augenklinik, Basel, Switzerland |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 07.09.2023 | |||||
| 2023-D0048 | Optimizing Beta Blocker Dosage in Women while Using the Wearable Cardioverter Defibrillator | clinical trial | medical devices | monocentric | A1 | PD Dr. med. Breitenstein, Alexander | ZOLL Medical Switzerland AG |
USZ, Zürich |
Kantonale Ethikkommission Zürich | 30.08.2023 | |||||
| 2023-D0047 | InvEstigation of the safety and performance of the NVT ALLEGRA Plus THV SysteM in Patients with severe aortIc stenosis or failed suRgical aortic bioprosthEsis | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Stefan Toggweiler | NVT GmbH |
Luzerner Kantonsspital, Luzern |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 03.08.2023 | |||||
| 2023-D0046 | Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of ISOPURE and EYHANCE Intraocular Lenses (IOL) Using a Double-masked Study Design | clinical trial | medical devices | monocentric | A1 | Dr. med Kristof Vandekerckhove | PhysIOL sa/nv |
Centre oculaire Vista Alpina, Sierre |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 24.07.2023 | |||||
| 2023-D0044 | Feasibility of unsupervised therapy after stroke in the home setting with a hand rehabilitation device (ReHandyBot): an exploratory study | clinical trial | medical devices | monocentric | C2 | Dr. med. Paolo Rossi | Rehabilitation Engineering Lab, ETH Zurich |
Clinica Hildebrand Centro di riabilitazione Brissago, Brissago |
Comitato etico cantonale Ticino | 28.08.2023 | |||||
| 2023-D0042 | CT-Guided Interventions using a patient mounted navigation system: Initial Clinical Experience | clinical trial | medical devices | monocentric | A1 | Dr. Med. Sebastian Kos | Universitätsspital Basel |
Klinik Hirslanden St. Anna, Lucerne |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 11.07.2023 | |||||
| 2023-D0040 |
Effect of monitoring continuous glucose levels and physical activity via wearables on cardiovascular risk factors after cardiac rehabilitation - A randomised controlled trial: MITIGATE-RF |
clinical trial | medical devices | monocentric | A1 | Dr. med. Jan Gerrit van der Stouwe | University Hospital Basel |
University Hospital Basel, Basel |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 07.06.2023 | |||||
| 2023-D0039 | Value of ultra-fast biparametric MRI in the assessment of prostate cancer | clinical trial | medical devices | monocentric | A1 | PD Dr. A. Hötker | University Hospital Zurich |
University Hospital Zurich, Zurich |
Kantonale Ethikkommission Zürich | 30.05.2023 | |||||
| 2023-D0037 | Assessment of the ankle joint axis using a long ankle view radiograph | clinical trial | medical devices | monocentric | A1 | Markus Knupp | Praxis "Mein Fusszentrum AG" |
Praxis "Mein Fusszentrum", Basel |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | 22.05.2023 | |||||
| 2023-D0033 | Study on preliminary safety and efficacy of the ARC Therapy using the ARC-IM Lumbar System to support mobility in people with chronic spinal cord injury | clinical trial | medical devices | monocentric | C2 | Prof. Dr. | Ecole Polytechnique Fédérale de Lausanne |
Jocelyne, Bloch |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 24.08.2023 | |||||
| 2023-D0032 | Air-polishing with erythritol on prevalence of white spot lesions and gingivitis during orthodontic treatment with fixed appliances: a randomized clinical trial of 2-years duration | clinical trial | medical devices | monocentric | A1 | Professor Giannopoulou Catherine | University Clinics of Dental Medicine |
University Clinics of Dental Medicine, Geneva |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 25.05.2023 | yes | ||||