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Dataset results
340 results for “Medical devices”
CE Mark Study for the Harpoon Medical Device
ClinicalTrials.gov study NCT02768870. IPD Sharing: NO. Countries: 2. Publications: 2.
Reciprocating Medical Devices - a Study of a New Safety Device
ClinicalTrials.gov study NCT00651625. IPD Sharing: NO. Countries: 1. Publications: 23.
Data from: Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts
Background: Medical devices are used widely for virtually every disease and condition. Although devices are subject to regulation, the number of recalls, the clinical data requirements for regulation and the impact on patient safety are poorly understood. Methods: The authors defined a device using European directives and used publicly available information on the Medicines and Health Regulatory Authority website to determine the number of devices recalled from January 2006 to December 2010. Two reviewers independently assessed Field Safety Notices and Medical Device Alerts. The authors wrote to manufacturers to obtain further information and clinical data, and summarised data by year, Conformité Européenne classification, indication, and Food and Drug Administration recall system of severity. Results: In total, 2124 field safety notices were issued over the 5-year period, an increase of 1220% (62 in 2006 to 757 in 2010). 447 Medical Device Alerts were issued in the same period, and 44% were assessed as a reasonable probability of causing serious adverse health consequences or death. The authors wrote to 192 manufacturers of withdrawn devices and received 101 (53%) replies; only four (2.1%) provided the clinical data the authors requested. A lack of available transparent data prevented full analyses of the safety impact. Of the highest-risk recalled devices, more than half were related to the cardiovascular system (25%) or musculoskeletal system (33%), and 88% (95% CI 80% to 97%) were assessed as a reasonable probability of causing serious adverse health consequences or death. For low-risk devices, the figure was 34% (95% CI 26% to 42%). Conclusion: The number of medical devices subject to recalls or warnings in the UK has risen dramatically. A substantial number of these devices may have caused serious adverse effects in patients and contributed to healthcare costs. Significant problems exist in the UK with a lack of access to transparent data and a registry of the highest-risk devices.
The Development of a Surgical Localizing Aid Medical Device
ClinicalTrials.gov study NCT01300520. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Usability of SMART ANGEL Medical Device to Record and Transmit Health Data From Patient's Home Following Outpatient Surgery
ClinicalTrials.gov study NCT03464721. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Prediction Medical Device for Rheumatoid Arthritis (PREDIRA)
ClinicalTrials.gov study NCT04147026. IPD Sharing: Not stated. Countries: 1. Publications: 6.
Evaluating the Performance and Safety of the Medical Device Plenhyage® in the Treatment of Dermal Tissue Defects
ClinicalTrials.gov study NCT05239117. IPD Sharing: Not stated. Countries: 1. Publications: 41.
Performance and Tolerability of the Medical Device LACRIACT
ClinicalTrials.gov study NCT06159569. IPD Sharing: NO. Countries: 1. Publications: 4.
Medication Adherence and Use of Inhaler Devices in Patients With Asthma or COPD
ClinicalTrials.gov study NCT06417931. IPD Sharing: NO. Countries: 1. Publications: 1.
The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1
ClinicalTrials.gov study NCT06419036. IPD Sharing: NO. Countries: 1. Publications: 3.
Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours
ClinicalTrials.gov study NCT01692379. IPD Sharing: Not stated. Countries: 1. Publications: 11.
Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women
ClinicalTrials.gov study NCT04887701. IPD Sharing: NO. Countries: 1. Publications: 1.
Evaluation of the Effect of the "CR500 SINGLE-DOSE GEL" Medical Device in Patients With Knee Osteoarthritis (KOA)
ClinicalTrials.gov study NCT05661162. IPD Sharing: UNDECIDED. Countries: 1. Publications: 1.
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
ClinicalTrials.gov study NCT06506721. IPD Sharing: NO. Countries: 1. Publications: 14.
BraiN20® Medical Device in Suspected Acute Stroke Patients
ClinicalTrials.gov study NCT06421337. IPD Sharing: NO. Countries: 1. Publications: 2.
A Comparative Trial Focusing on Injections With the Medical Device DV3316 Pen-injector Versus FlexPen®
ClinicalTrials.gov study NCT02627287. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Self-guided vs Traditional Instructor-led Learning for Medical Device Training
ClinicalTrials.gov study NCT05530382. IPD Sharing: NO. Countries: 1. Publications: 2.
The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device
ClinicalTrials.gov study NCT02079792. IPD Sharing: Not stated. Countries: 1. Publications: 6.
Study to Evaluate the Performance and Safety of the Medical Device Argogen
ClinicalTrials.gov study NCT05649332. IPD Sharing: Not stated. Countries: 1. Publications: 30.
An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias
ClinicalTrials.gov study NCT04750798. IPD Sharing: YES. Countries: 12. Publications: 0.
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