| 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-D0110 | Brain aging – a comparative study in healthy and patients with Multiple Sclerosis as model of a chronic neuroinflammatory disorder | clinical trial | medical devices | monocentric | C2 | PD Dr. med Robert Hoepner | Inselgruppe AG |
Inselgruppe AG, Bern |
Kantonale Ethikkommission Bern | 07.03.2024 | |||||
| 2023-D0109 | Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect (ASCENT ASD Study) | clinical trial | medical devices | multicentric | C2 | Prof Dr med Oliver Kretschmar | atHeart Medical LLC |
KISPI, Zurich CHUV, Rue de Bugnon 21 |
Kantonale Ethikkommission Zürich | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 28.05.2024 | yes | |||
| 2023-D0108 | PREPICare: Assessment of an Innovative Air Mattress on Critically Ill Infants | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Barbara Brotschi Audenblatten | Empa |
Universitätskinderspital Zürich, Zürich |
Kantonale Ethikkommission Zürich | 19.03.2024 | yes | Study has ended | |||
| 2023-D0107 | A Non-Randomized, Prospective or Retrospective, Open-Label, Multi-Center, Observational Clinical Study with Two Arms to Further Evaluate Safety and Performance of the NEXUS® Aortic Arch Stent Graft Sy More ... | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med. Mario Lachat | Endospan ltd |
Hirslanden Klinik, Zürich |
Kantonale Ethikkommission Zürich | 12.12.2023 | |||||
| 2023-D0106 | Exploratory study of NeuroLF, an investigational medical device without CE-marking for PET imaging of the human brain | clinical trial | medical devices | monocentric | C2 | Prof. Dr. Martin Hüllner | Positrigo AG |
University Hospital Zurich, Zurich |
Kantonale Ethikkommission Zürich | 14.05.2024 | |||||
| 2023-D0105 | A mobile application as supportive treatment of endometriosis: the effect on quality of life and endometriosis-associated pain. A randomized controlled trial. | clinical trial | medical devices | monocentric | A1 | Dr. med. Marietta Gulz | University Hospital of Obstetrics and Gynaecology |
University Hospital of Bern Department of Gynecology and Obstetrics, Bern |
Kantonale Ethikkommission Bern | 20.12.2023 | |||||
| 2023-D0103 | Safety and performance of the Biphasic Plate Distal Femur: A multicenter case series | clinical trial | medical devices | multicentric | A1 | Dr.Med Christian Michelitsch | 41medical AG |
Kantonsspital Graubunden, Chur University Hospital Basel, Department of Orthopaedics and Traumatology Unive Universitätsspital Zürich, Rämistrasse 100 |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Zürich, Ethikkommission Nordwest- und Zentralschweiz EKNZ | 23.01.2024 | ||||
| 2023-D0102 | Brain Controlled Spinal Cord Stimulation in Participants with Spinal Cord Injury for Lower Limb Rehabilitation | clinical trial | medical devices | monocentric | C2 | Prof. Dr. Jocelyne Bloch | EPFL SV BMI UPCOURTINE |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 14.03.2024 | |||||
| 2023-D0101 | A multicentric, prospective clinical investigation to evaluate microwave imaging via MammoWave® in a population-based screening program for early breast cancer detection to make breast cancer screeni More ... | clinical trial | medical devices | monocentric | C2 | Prof. Thomas Frauenfelder | Umbria Bioenergeenering Technologies (UBT) srl |
University Hospital Zurich, Zurich |
Kantonale Ethikkommission Zürich | 07.06.2024 | |||||
| 2023-D0100 | Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation from a Rocking Bed (Somnomat Casa) – A Feasibility Study | clinical trial | medical devices | monocentric | C2 | Dr. med. Lenard Lachenmayer | Inselspital, Universitätsspital Bern |
Inselspital, University Hospital, Bern |
Kantonale Ethikkommission Bern | 11.01.2024 | |||||
| 2023-D0097 |
CAMBRIA-2 (ClinO-MD) A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standar More ... |
clinical trial | in vitro diagnostic medical devices IVD-MD | multicentric | C2 | Dr. med. Ursina Zürrer-Härdi | AstraZeneca AB |
Kantonsspital Winterthur, Klinik für Medizinische Onkologie und Hämatologie, Winterthur Kantonsspital Baden, Im Ergel Hirslandenklinik St. Anna, Zentrum für Onkologie St. Anna-Strasse 32 Universitäts More ... |
Kantonale Ethikkommission Zürich | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Ethikkommission Ostschweiz (EKOS), Kantonale Ethikkommission Zürich, Ethikkommission Nordwest- und Zentralschweiz EKNZ, More ... | 28.03.2024 | ||||
| 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-D0094 | A Single-Arm Pilot Study to Evaluate the Safety of Adipearl Injection in the Subcutanaeous Tissues of Adults | clinical trial | medical devices | monocentric | C2 | Dr. Johann Wary | Volumina Medical S.A. |
Summit Clinic, Crans-Montana |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 19.01.2024 | |||||
| 2023-D0093 | Immediate Placement and Stabilization of Dental Implants with Tetranite® Implant Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites that Fail to Provide Adequate Primary Stabili More ... | clinical trial | medical devices | multicentric | C2 | Prof. Dr. med. dent. Patrick R. Schmidlin | RevBio, Inc |
Center of Dental Medicine, University of Zürich, Zürich Universitat Bern, Bern |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Bern | 23.02.2024 | ||||
| 2023-D0092 | Mid- oder high-flex Stäbe versus low-flex Stäbe von SpineShape System IV zur Behandlung der degenerativen Lendenwirbelsäule - eine prospektive, multizentrische, randomisiert kontrollierte Non-Inferior More ... | clinical trial | medical devices | multicentric | C3 | Dr. med. Philipp Cathrein | SpineSave AG |
Hirslanden Klinik Linde, Biel Spital Aarberg, Aarberg |
Kantonale Ethikkommission Bern | Kantonale Ethikkommission Bern | 27.02.2024 | ||||
| 2023-D0089 | Pharmacoscopy-guided clinical standard-of-care in relapsed/refractory acute myeloid leukemia, a randomized phase-2 clinical trial | clinical trial | in vitro diagnostic medical devices IVD-MD | multicentric | C2 | Prof. Dr. med. Alexandre Theocharides | ETH Zurich |
University Hospital Zurich, Zurich Inselspital Bern, Bern |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Bern | 07.05.2024 | ||||
| 2023-D0088 | Clinical evaluation of a new flowable composite for direct restorative treatment of non-carious cervical lesions: A prospective randomized split-mouth study | clinical trial | medical devices | monocentric | C2 | Dr. med. dent. Carola Pentelescu | Ivoclar Vivadent AG |
Ivoclar Vivadent AG, Schaan |
Kantonale Ethikkommission Zürich | 16.01.2024 | |||||
| 2023-D0087 |
A randomized, sham-controLled, clinical Trial For evaLuation Of the EdWards APTURE transcatheter shunt system (ALT-FLOW II) |
clinical trial | medical devices | multicentric | C2 | Prof. Dr. med. Lukas Hunziker Munsch | Edwards Livesciences LLC |
Bern University Hospital, Inselspital, Bern Universitätsspital Basel, Universitäres Herzzentrum, Kardiologie |
Kantonale Ethikkommission Bern | Ethikkommission Nordwest- und Zentralschweiz EKNZ | 26.03.2024 | ||||
| 2023-D0086 | Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter | clinical trial | medical devices | monocentric | C2 | Prof. Juerg Schwitter | Imricor Medical Systems, Inc |
University Hospital Lausanne (CHUV), Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 26.02.2024 | |||||
| 2023-D0084 | EFFICACY AND SAFETY OF THE CG-100 INTRALUMINAL BYPASS DEVICE IN COLORECTAL AND COLOANAL ANASTOMOSES: PROSPECTIVE, OPEN LABEL, RANDOMIZED, TRIAL | clinical trial | medical devices | monocentric | A1 | Dr. Dieter Hahnloser | Colospan Ltd |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 09.02.2024 | |||||