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 | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
2023-00300 | Understanding the reasons for delayed referral for debridement, antibiotics and implant retention (DAIR) in patients with acute periprosthetic joint infections | non clinical, involving persons | multicentric | A | Prof. Dr. med. Parham Sendi | University of Bern |
University of Bern, Institut for Infectious Diseases, Bern University Hospital of Basel, Basel Kantonsspital Baselland, Bruderholz Kantonsspital St.Gallen, St. Gallen Balgrist Universitätsklinik, Züri More ... |
Kantonale Ethikkommission Bern | Ethikkommission Nordwest- und Zentralschweiz EKNZ, Ethikkommission Ostschweiz (EKOS), Kantonale Ethikkommission Zürich | 16.03.2023 | |||||
2023-00245 | Effect of a digital lifestyle intervention on health-related quality of life in non-small cell lung cancer survivors after inpatient rehabilitation (QUALUCA): a multicenter randomized controlled trial | clinical trial | other clinical trials | multicentric | A | PD Dr. Anja Frei | Berner Fachhochschule |
Universität Zürich, Zürich Berner Reha Zentrum AG, 3625 Heiligenschwendi Klinik Barmelweid, 5017 Barmelweid |
Kantonale Ethikkommission Zürich | Ethikkommission Nordwest- und Zentralschweiz EKNZ, Kantonale Ethikkommission Bern | 21.03.2023 | ||||
2023-00127 | A comparative assessment of Bionator and Activator appliances in the treatment of Class II malocclusion: a retrospective cohort study. | personal data/biological material | multicentric | Prof. Dr. mult. Theodore Eliades | Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich |
Clinic of Orthodontics and Pediatric Dentistry, Center of Dental Medicine, University of Zurich, Zurich Kinder- und Jugendzahnklinik St.Gallen, St.Gallen Praxis Dr. med. dent. Tim Schröder AG, Herisau |
Ethikkommission Ostschweiz (EKOS) | Ethikkommission Ostschweiz (EKOS) | 02.02.2023 | ||||||
2023-00097 | SwissLEGIO-CAP: a multicentre case-control study on clinical, laboratory and radiological characteristics of community-acquired Legionnaires’ disease | personal data/biological material | multicentric | Prof Daniel Mäusezahl | Swiss Tropical and Public Health Institute |
Swiss Tropical and Public Health Institute, Allschwil Universitätsspital Basel, 4031 Basel Kantonsspital St. Gallen, 9007 St. Gallen |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Ethikkommission Nordwest- und Zentralschweiz EKNZ, Ethikkommission Ostschweiz (EKOS) | 08.03.2023 | ||||||
2023-00028 | Solitaire X 3 mm as the first-line device for the treatment of acute ischemic stroke – a multicentre retrospective case series | personal data/biological material | multicentric | Prof Marios Psychogios | University Hospital Basel |
Universitätsspital Basel, Basel Kantonsspital Aarau AG, Aarau |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Ethikkommission Nordwest- und Zentralschweiz EKNZ | 02.02.2023 | ||||||
2022-D0121 | Clinical performance study for use of the Vysis MET FISH Probe Kit for the identification of patients with EGFR mutated MET-amplified, locally advanced or metastatic non-small cell lung cancer who hav More ... | clinical trial | in vitro diagnostic medical devices | multicentric | C2 | Dr. med. David König | AstraZeneca AB |
Universitätsspital Basel, Basel Stadtspital Zürich Triemli, Birmensdorferstrasse 497 |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Zürich | 01.02.2023 | ||||
2022-D0120 | Clinical Performance Study Plan for use of the MET (SP44) IHC Clinical Trial Assay in D5087C00001, A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Plati More ... | clinical trial | in vitro diagnostic medical devices | multicentric | C2 | Dr. med David König | AstraZeneca AB |
Universitätsspital Basel, Basel Stadtspital Zürich Triemli, Birmensdorferstrasse 497 |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Zürich | 22.02.2023 | ||||
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-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 | ||||
2022-D0099 | EndurAnt Stent Graft system vs ExcluDer endoprothesis: 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-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), Commission Cantonale d'éthique de la recherche Genève (CCER) | 04.01.2023 | ||||
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 | |||
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-D0064 |
The relevance of the preoperative marker technique for efficient and safe targeted axillary dissection in patients with breast cancer -A prospective, randomized, multi-center trial |
clinical trial | medical devices | multicentric | A1 | Dr. Med. Constanze Elfgen | Brust-Zentrum Zürich |
Brust-Zentrum Zürich, Zürich Brustzentrum Bern Biel, Standort Bern, Bern Brustzentrum Kantonsspital Baden, Im Ergel 1 Tumor- und Brustzentrum Ostschweiz, Rorschacherstrasse 286 |
Kantonale Ethikkommission Zürich | Kantonale Ethikkommission Bern, Ethikkommission Ostschweiz (EKOS), Ethikkommission Nordwest- und Zentralschweiz EKNZ | 06.02.2023 | ||||
2022-D0062 | Safety and performance using SMILE with the VisuMax femtosecond laser system optimized for Presbyopia | clinical trial | medical devices | multicentric | C2 | Dr. Patrick Titzé | Carl Zeiss Meditec AG |
MV SANTE VISION, Sion MV Sante Vision (Main Site), Rue de Lausanne 27 MV SANTE VISION S.A. (Satellite site), Avenue de Rhodanie 70 |
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) | 09.12.2022 | ||||
2022-D0050 | The PROGRESS Trial - A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement | clinical trial | medical devices | multicentric | C1 | Prof. Dr. Markus Kasel | Edwards Lifesciences LLC |
Universitäres Herzzentrum, Zürich Unité de cardiologie structurelle, Département de Médicine Service de cardiologie R |
Kantonale Ethikkommission Zürich | Commission Cantonale d'éthique de la recherche Genève (CCER) | 25.11.2022 | ||||
2022-D0044 | ProSPective evaluation of the dIagnostic accuracy of siNe spiN non-contrast flat-dEtectoR CT (FDCT) for the detection of intracranial hemorrhage in Stroke patients - an open labelled, multicenter, non More ... | clinical trial | medical devices | multicentric | A2 | Prof. Marios-Nikos Psychogios | University Hospital Basel |
University Hospital Basel, Basel Inselspital Bern, Bern Kantonsspital Luzern, Sektion für Neuroradiologie |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Bern, Ethikkommission Nordwest- und Zentralschweiz EKNZ | 05.07.2022 | ||||
2022-D0042 | Effectiveness of the SpaceOAR Vue System in Subjects with Prostate Cancer being Treated with Stereotactic Body Radiotherapy | clinical trial | medical devices | multicentric | A1 | Dr Jens Lustenberger | Boston Scientific Corporation |
University Hospital Basel, Basel Universitätsklinik für Radio-Onkologie, Inselspital, Bern |
Ethikkommission Nordwest- und Zentralschweiz EKNZ | Kantonale Ethikkommission Bern | 20.09.2022 | ||||
2022-D0034 | Fully closed-loop insulin delivery in abdominal surgery: a randomised controlled two-centre trial (CLAB-Study) | clinical trial | medical devices | multicentric | A1 | Prof. Lia Bally | Inselspital, Bern University Hospital, University of Bern |
Inselspital Bern, University Hospital Bern and University of Bern, Bern University Hospital Basel, Anaesthesiology Spitalstrasse 21 |
Kantonale Ethikkommission Bern | Ethikkommission Nordwest- und Zentralschweiz EKNZ | 16.06.2022 | ||||
2022-D0024 |
Single Shot Pulmonary Vein Isolation: Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation – A Multi-Center Non-Inferiority Design Clinical More ... |
clinical trial | medical devices | multicentric | A2 | Prof. Dr. Tobias Reichlin | Universitätsklinik für Kardiologie |
Inselspital, Universitätsspital Bern, Bern University Hospital Basel, Department of Cardiology |
Kantonale Ethikkommission Bern | Ethikkommission Nordwest- und Zentralschweiz EKNZ | 30.06.2022 | ||||