| 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-D0108 | BRAIN CONTROLLED SPINAL CORD STIMULATION IN PARTICIPANTS WITH CERVICAL SPINAL CORD INJURY FOR UPPER LIMB REHABILITATION | clinical trial | medical devices | monocentric | C2 | Prof. Jocelyne Bloch | EPFL SV BMI UPCOURTINE |
CHUV, Lausanne |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | 25.04.2023 | |||||
| 2022-D0107 | A post-market registry study based on standard clinical care to assess safety and performance of RefluxStop™ in the treatment of Gastroesophageal Reflux Disease (GERD) in general hospital practice. | clinical trial | medical devices | multicentric | A1 | Dr. med. / Yves / Borbély | Implantica CE Reflux Ltd. |
Inselspital, Bauchzentrum, Bern Hirslanden Klinik Beau‐Site Bern, Bern |
Kantonale Ethikkommission Bern | Kantonale Ethikkommission Bern | 29.11.2022 | ||||
| 2022-D0106 | Cantilever restorations on short and longer dental implants - a randomized controlled clinical trial | clinical trial | medical devices | monocentric | A1 | Prof. Dr. med. dent. Daniel S. Thoma | Center of Dental Medicine |
Center of Dental Medicine, Zurich |
Kantonale Ethikkommission Zürich | 10.01.2023 | |||||
| 2022-D0105 | Assistance and evaluation of the post-stroke rehabilitation process via the analysis of High-Density surface EMG signals acquired with the WPM-SEMG-V2 device: A single centre, prospective, feasibility More ... | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Alain Kaelin | Ente Ospedaliero Cantonale |
Istituto di Neuroscienze Cliniche della Svizzera Italiana EOC, Lugano |
Comitato etico cantonale Ticino | 19.12.2022 | |||||
| 2022-D0103 |
Tina-quant Lp(a) RxDx Phase III Trial Sample Measurement Short title: Measurement of Patient Samples with Lp(a) assay |
clinical trial | in vitro diagnostic medical devices | multicentric | C2 | Professor Stephan Windecker | Roche Diagnostics International Ltd |
Insel Gruppe AG, Bern University Hospital, Department of Cardiology, Bern Universitaetsspital Basel, Petersgraben 4,Kardiologie,Universitaetsspital Bas Hopitaux Universitaires de Geneve, Service de Ca More ... |
Kantonale Ethikkommission Bern | 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 ... | 24.01.2023 | Study has ended | |||
| 2022-D0102 | 3D planned surgery of acute fractures performed with 3D guides printed at the point of care – a prospective case series | clinical trial | medical devices | monocentric | A1 | Dr.med. Andreas Hecker | Inselspital Bern |
Inselspital, Bern |
Kantonale Ethikkommission Bern | 27.01.2023 | |||||
| 2022-D0101 | Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation – APOLLO-EU Trial | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med. Stephan Windecker | Medtronic Bakken Research Center B.V. |
Inselspital, Universitätsspital Bern, Bern |
Kantonale Ethikkommission Bern | 02.05.2023 | |||||
| 2022-D0100 | CARDIAC FLOW MEASUREMENTS IN PREGNANT WOMEN BY NON INVASIVE TECHNIQUES: COMPARISON BETWEEN USCOM, ICON and TRANS THORACIC ECHOGRAPHY. | clinical trial | medical devices | monocentric | A1 | Dr Bénédicte LE TINIER | Hôpitaux Universitaires de Genève |
Hopitaux universitaires de Genève, Geneva |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 16.01.2023 | |||||
| 2022-D0099 | EndurAnt Stent Graft system vs ExcluDer endoprosthesis: a global, prospectiVe, rANdomized Clinical trial in sac rEgression | clinical trial | medical devices | multicentric | A1 | Dr. Sébastien Déglise | Medtronic Bakken Research Center |
Centre hospitalier universitaire vaudois, Lausanne Luzerner Kantonsspital, Spitalstrasse |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | Ethikkommission Nordwest- und Zentralschweiz EKNZ | 17.01.2023 | ||||
| 2022-D0098 | Real-time deflectable guidewire in neuro-interventions study (SmartGUIDE) | clinical trial | medical devices | monocentric | C2 | Prof. Dr. Paolo Machi | Artiria Medical SA |
Geneva University Hospital - HUG, Geneva |
Commission Cantonale d'éthique de la recherche Genève (CCER) | 03.04.2023 | |||||
| 2022-D0097 | First clinical evaluation of a novel non-invasive glucose sensor technology in patients with type 1 diabetes: a single-arm pilot study | clinical trial | medical devices | monocentric | C2 | Prof. Dr. med Markus Laimer | DCB Research AG |
Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM), Inselspital, Bern |
Kantonale Ethikkommission Bern | 03.02.2023 | Study has ended | ||||
| 2022-D0096 | An Open-label Randomized Phase 3 Study of Tucatinib in Combination with Trastuzumab and mFOLFOX6 versus mFOLFOX6 given with or without either Cetuximab or Bevacizumab as First-line Treatment for Subje More ... | clinical trial | in vitro diagnostic medical devices | multicentric | C1 | Dr. Ralph Fritsch | Seagen Inc. |
Universitätsspital Zürich, Klinik für Medizinische Onkologie und Hämatologie, Zürich Kantonsspital Winterthur, Brauerstr. 15 |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Zürich | 30.06.2023 | ||||
| 2022-D0094 | A Prospective, Randomized, Blinded Evaluator, Multicenter, Clinical Study to Evaluate Safety and Effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face. | clinical trial | medical devices | multicentric | C2 | Dr Navid Alizadeh | TEOXANE SA |
Care Geneva Aesthetics, Geneva Clinique Cleage, Place du Molard 5 Private clinic, Avenue de Champel 24 Clinique des Grangettes, Route de Chêne 110 Clinique de la Croix d’Or, Rue de la Croix-d’Or 7 CHU More ... |
Commission Cantonale d'éthique de la recherche Genève (CCER) | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Kantonale Ethikkommission Zürich, Commission Cantonale d'éthique de la recherche Genève (CCER) | 04.01.2023 | ||||
| 2022-D0093 | Post-Market, Randomized, Controlled, Multicenter, Prospective Trial Investigating Efficacy and Safety of Paclitaxel-Coated Drug Coated Balloon (LEGFLOW DCB) Treatment versus Uncoated Balloon Angioplas More ... | clinical trial | medical devices | multicentric | A1 | Dr. med. Nicolas Villard | Cardionovum GmbH |
CHUV Radiodiagnostic et Radiologie Interventionnelle, Lausanne INSELSPITAL, Universitätsklinikum Bern, Bern Hôpital de La Providence, Hôpital, Clinique Cabinet médical Dr Amine Chouit |
Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD), Kantonale Ethikkommission Bern | 27.03.2023 | ||||
| 2022-D0092 |
Assessing the symptomatic benefit of slow-wave activity reduction using wearables and sensor-based characterization of depression: a randomized, counter-balanced crossover study |
clinical trial | medical devices | monocentric | C2 | Dr. Giulia Da Poian | ETHZ - Department of Health and Science Technology |
ETH Zurich, Zurich |
Kantonale Ethikkommission Zürich | 20.12.2022 | |||||
| 2022-D0091 | Radio-ablation of malignant primary liver lesions (hepato-cellular carcinoma, HCC), followed by surgical resection (ablate – resect) | clinical trial | medical devices | monocentric | C2 | MD Alessandra Cristaudi | BetaGlue Technologies SpA |
Ente Ospedaliero Cantonale (EOC) Ospedale Regionale di Lugano – Civico Dipartimento di Chirurgia, Lugano |
Comitato etico cantonale Ticino | 06.03.2023 | |||||
| 2022-D0090 | Beurteilung der Sichtbarkeit anatomischer Strukturen der Zähne, des Zahnhalteapparats, der angrenzenden anatomischen Regionen und der Lagebeziehungen in der Weisheitszahnregion durch optimierte Verwen More ... | clinical trial | medical devices | monocentric | A1 | Dr. Silvio Valdec | Universität Zürich |
Universität Zürich, Zürich |
Kantonale Ethikkommission Zürich | 22.11.2022 | |||||
| 2022-D0087 | Simplified meal approach study using hybrid closed-loop insulin delivery in youth and young adults with type 1 diabetes – a randomised controlled two-centre crossover trial | clinical trial | medical devices | multicentric | A1 | Prof. Dr. med. et Dr. phil. Lia Bally | Universitätsklinik für Diabetologie, Endokrinologie, klinische Ernährung und Metabolismus Inselspital Bern |
Universitätsklinik für Diabetologie, Endokrinologie, klinische Ernährung und Metabolismus, Bern Abteilung Endokrinologie und Diabetologie, Universitäts-Kinderspital Zürich, Abteilung Endokrinologie u More ... |
Kantonale Ethikkommission Bern | Kantonale Ethikkommission Zürich | 25.11.2022 | yes | Study has ended | ||
| 2022-D0086 |
Prospective Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumours ≤15 mm (BR-003) |
clinical trial | medical devices | multicentric | A2 | Dr Heike Frauchiger-Heuer | Novian Health Inc |
University Hospital Zurich, Zurich Breast Centre Zurich, Seefeldstrasse 214 |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Zürich | 22.11.2022 | ||||
| 2022-D0085 | Physician Initiated Trial Investigating ESAR (EVAR plus Heli-FX EndoAnchors) and FEVAR for the treatment of aortic aneurysms with short infrarenal aortic neck. | clinical trial | medical devices | monocentric | A1 | Prof Dr med Drosos Kotelis | FCRE - Foundation for Cardiovascular Research and Education GmbH |
Inselspital, Universitätsspital Bern Universitätsklinik für Gefässchirurgie Herz Gefäss Zentrum, Bern |
Kantonale Ethikkommission Bern | 24.02.2023 | |||||