| 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 | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021-D0090 | Stereoptic serious games as a visual rehabilitation tool for individuals with residual paediatric amblyopia: A crossover randomized controlled trial | clinical trial | medical devices | monocentric | A1 | Dr Pawel Matusz | University of Applied Sciences Western Switzerland (HES-SO) Valais |
University of Applied Sciences Western Switzerland (HES-SO) Valais, Sierre |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 22.02.2022 | yes | ||||
| 2021-D0089 | Clinical outcomes following non-surgical mechanical therapy of peri-implant mucosisits with or without adjunctive enamel matrix derivative: A 6-month randomized clinical trial | clinical trial | medical devices | monocentric | A1 | Prof. Giovanni Salvi | Department of Periodontology, University of Bern |
Department of Periodontology, University of Bern, Bern |
Kantonale Ethikkommission Bern | 20.05.2022 | |||||
| 2021-D0087 | Effects of concurrent tACS-iTBS on neural plasticity in the prefrontal cortex | clinical trial | medical devices | monocentric | A1 | PD Dr. med. Yosuke Morishima | University Hospital of Psychiatry Bern |
University Hospital of Psychiatry and Psychotherapy, Bern |
Kantonale Ethikkommission Bern | 24.01.2022 | |||||
| 2021-D0086 | LIVIA 2.0: A randomized controlled trial of two French internet intervention for adults struggling with prolonged grief symptoms after the loss of a close one (by bereavement or separation/divorce) | clinical trial | medical devices | monocentric | C2 | Dr Valentino Pomini | UNIL - Institut Psychologie |
University of Lausanne, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 10.02.2022 | |||||
| 2021-D0085 | Clinical performance of lithium disilicate and hybrid ceramic for the restoration of worn posterior dentitions - A randomized controlled split-mouth trial. | clinical trial | medical devices | monocentric | A1 | PD Dr. med. dent. Alexis Ioannidis | University of Zurich, Center of Dental Medicine, Clinic of Reconstructive Dentistry |
University of Zurich, Center of Dental Medicine, Clinic of Reconstructive Dentistry, Zurich |
Kantonale Ethikkommission Zürich | 12.04.2022 | |||||
| 2021-D0083 | Comparison of cerebral oxygenation values on healthy volunteers measured with RheoPatch and NIRO-200NX | clinical trial | medical devices | monocentric | A1 | Daniel Gerber | Inselspital Bern, Klinik für Anästhesiologie und Schmerztherapie |
Inselspital, Bern |
Kantonale Ethikkommission Bern | 21.04.2022 | |||||
| 2021-D0082 | The efficacy of CytoSorb in the removal of IL-6 in severe aneurysmal subarachnoid hemorrhage (aSAH) – a two phase study – a primary feasibility study (phase 1) – a secondary randomized, controlled, pr More ... | clinical trial | medical devices | monocentric | A1 | Prof. Dr. Emanuela Keller | UniversitätsSpital Zürich |
UniversitätsSpital Zürich, Zürich |
Kantonale Ethikkommission Zürich | 18.01.2022 | Study has ended | ||||
| 2021-D0081 | Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI DTU Trial | clinical trial | medical devices | multicentric | C1 | PD. Dr. med. Florim Cuculi | Abiomed Inc. |
Luzerner Kantonspital, Herzzentrum Luzern, Luzern Inselspital, Universitätsspital Bern, Bern |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Bern | 30.03.2022 | ||||
| 2021-D0080 | Impella®-Supported PCI in High-Risk Patients with Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial | clinical trial | medical devices | multicentric | A2 | Prof. Lukas Hunziker Munsch | Abiomed Europe GmbH |
Inselspital, Universitätsspital Bern, Bern Luzerner Kantonsspital, Luzerner Kantonsspital Spitalstrasse 6000 Luzern Cardiocentro Ticino Institute, Via Tesserete 48 |
Kantonale Ethikkommission Bern | Ethikkommission Nordwest- und Zentralschweiz EKNZ, Comitato etico cantonale Ticino | 16.03.2022 | ||||
| 2021-D0079 | A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic More ... | clinical trial | medical devices | multicentric | C2 | Prof. Dr. Jos van den Berg | MedAlliance LLC |
Ospedale Regionale di Lugano, Lugano University of Bern, Bern |
Comitato etico cantonale Ticino | Kantonale Ethikkommission Bern | 27.04.2022 | ||||
| 2021-D0078 | An Interventional, Post-Market Study to Evaluate the Performance of a Custom-made Medical Device, “Breast Cancer Locator Guidance (BCL)” System, in Breast-conserving Surgery (BCS) | clinical trial | medical devices | multicentric | A1 | MD SD Claudia Canonica | CairnSurgical Inc. |
Ospedale Regionale di Bellinzona e Valli, Bellinzona Spital Zollikerberg, BrustCentrum Spital Zollikerberg Trichtenhauserst |
Comitato etico cantonale Ticino | Kantonale Ethikkommission Zürich | 13.01.2022 | ||||
| 2021-D0077 | ePRO for the Timely Detection of Side Effects in Cancer Patients Undergoing CAR T Immunotherapy: Feasibility Study | clinical trial | medical devices | monocentric | A1 | PD Dr. med. Panagiotis Samaras | Stiftung Swiss Tumor Institute |
Klinik für Hämatologie und Onkologie Hirslanden, Zürich |
Kantonale Ethikkommission Zürich | 01.02.2022 | Study has ended | ||||
| 2021-D0076 | A Prospective Open-Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients with Paroxysmal Atrial Fibrillation | clinical trial | medical devices | multicentric | A1 | Prof. Dr. Tobias Reichlin | FARAPULSE, Inc |
Inselspital - Universitätsspital Bern, 3010 Bern University Hospital Basel, Professor of Cardiology Petersgaben 4 |
Kantonale Ethikkommission Bern | Ethikkommission Nordwest- und Zentralschweiz EKNZ | 14.03.2022 | ||||
| 2021-D0074 | Prospective evaluation of the Laryngeal Mask Singularity® in adult patients under clinical conditions | clinical trial | medical devices | monocentric | A1 | PD Dr. Alexander Dullenkopf | Spital Thurgau Frauenfeld |
Spital Thurgau, Frauenfeld |
Ethikkommission Ostschweiz (EKOS) | 10.12.2021 | |||||
| 2021-D0072 | A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy-ineligible Elderly Pati More ... | clinical trial | medical devices | multicentric | C1 | PD Dr. Laurent Muller | NANOBIOTIX S.A. |
Universitätsspital Basel, Basel Inselspital, Universitätsspital Bern, Bern |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Bern | 05.05.2022 | ||||
| 2021-D0071 | Single-center prospective clinical trial to validate the performance of the Aktiia optical blood pressure monitoring (OBPM) device at the wrist against double auscultation | clinical trial | medical devices | monocentric | C2 | Dr. Grégoire Wuerzner | Aktiia SA |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 10.01.2022 | |||||
| 2021-D0070 | Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a Premium Monofocal Intraocular lens (IOL) in Comparison to an EDOF Lens | 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) | 02.02.2022 | |||||
| 2021-D0068 | Intra-observer variability in the assessment of cervical stiffness with the Pregnolia System | clinical trial | medical devices | monocentric | A1 | Dr. med. Gundula Hebisch | Pregnolia AG |
Kantonsspital Frauenfeld, Frauenfeld |
Ethikkommission Ostschweiz (EKOS) | 21.12.2021 | |||||
| 2021-D0067 | Repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of affective symptoms in patients suffering from dementia: a randomised clinical trial | clinical trial | medical devices | monocentric | A1 | Pr Armin von Gunten | CHUV |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 27.01.2022 | |||||
| 2021-D0066 | Pilot study on response assessment during MR-guided radiation therapy for glioblastoma multiforme | clinical trial | medical devices | monocentric | A1 | Prof. Dr. Nicolaus Andratschke | Universitätsspital Zürich |
University Hospital of Zurich, Zurich |
Kantonale Ethikkommission Zürich | 18.01.2022 | |||||