Clinical trials: Surveillance
Menorrhagia, Dysmenorrhea
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including…
- Trial name
- J-MIRAI (NCT02475356)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 601 people
- Sponsor
- Bayer
Peripheral Artery Disease
Acotec DCB Post Market Clinical Follow-up
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical…
- Trial name
- FLOWER (NCT04393389)
- Testing
- AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
- Where
- 7 sites in Germany
- Volunteers
- 3,000 people
- Sponsor
- Acotec Scientific Co., Ltd
Papillomavirus Infections
GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)
This study will collect safety information on the use of GARDASIL™ in the Philippines.
- Trial name
- NCT01355003
- Volunteers
- 1,080 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Zika Virus Disease
Zika Case Definition and Surveillance Study
This prospective, surveillance study will assess the operational Zika virus definition for use in future Zika purified inactivated virus (ZIKV) vaccine efficacy trials in order to identify Zika virus disease (ZVD) cases among the…
- Trial name
- NCT03158233
- Where
- 6 sites in Colombia, Honduras and 2 more
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Localized Prostate Cancer
WATER IV PCa (AS Sub-study)
The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.
- Trial name
- NCT07650448
- Testing
- Aquablation Therapy, Active Surveillance
- Where
- 27 sites in United States, Hong Kong
- Volunteers
- 333 people
- Sponsor
- PROCEPT BioRobotics
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Breast Cancer
AryoTrust® (Trastuzumab) Safety Study
This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant…
- Trial name
- NCT06021379
- Testing
- Trastuzumab
- Where
- 15 sites in Iran
- Volunteers
- 597 people
- Sponsor
- AryoGen Pharmed Co.
Diabetes Mellitus Type 2
Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about…
- Trial name
- NCT02090673
- Testing
- Exenatide
- Where
- South Korea
- Volunteers
- 1,711 people
- Sponsor
- AstraZeneca
Hypertension
Study to Evaluate Efficacy and Tolerability of Micardis®/Micardis® Plus in Patients With Hypertension
Study to evaluate efficacy and tolerability of Micardis®/Micardis® Plus under usual daily-practice prescribing conditions in hypertensive patients
- Trial name
- NCT02242357
- Testing
- Micardis®, Micardis® Plus
- Volunteers
- 14,553 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
Faslodex Post Marketing Surveillance
This PMS aims to assess the efficacy, the safety and tolerability profile of Faslodex in everyday practice. Secondary objective of this PMS is to identify the frequency of serious adverse events or any unknown adverse events of…
- Trial name
- NCT00860561
- Where
- 7 sites in South Korea
- Volunteers
- 42 people
- Sponsor
- AstraZeneca
Overactive Bladder (OAB)
Drug Use Investigation for Toviaz
The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
- Trial name
- NCT01936870
- Testing
- Fesoterodine (Toviaz)
- Volunteers
- 2,521 people
- Sponsor
- Pfizer
Healthy
Prevenar13 Post Market Surveillance
It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine.
- Trial name
- NCT01509105
- Testing
- 13-valent pneumococcal vaccine
- Where
- 18 sites in South Korea
- Volunteers
- 649 people
- Sponsor
- Pfizer
Diagnostic Imaging
Magnevist Post-marketing Surveillance in Japan
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral…
- Trial name
- NCT01376739
- Testing
- Gadopentetate dimeglumine (Magnevist, BAY86-4882)
- Where
- Japan
- Volunteers
- 2,051 people
- Sponsor
- Bayer
Cardiovascular Procedures, Thoracic Aortic Aneurysm
Post Market Surveillance Study Evaluating BioFoam Surgical Matrix in Cardiovascular Surgery
This is a prospective, multicenter, single-arm study designed to collect clinical data to support the safety and effectiveness of BioFoam used as a surgical adjunct to anastomotic hemostasis following cardiovascular surgery.
- Conditions
- Cardiovascular Procedures, Thoracic Aortic Aneurysm, Aortic Valve Replacement, Type A Aortic Dissection
- Trial name
- NCT02164201
- Where
- 2 sites in Germany, Italy
- Volunteers
- 75 people
- Sponsor
- CryoLife Europa
Rheumatoid Arthritis, Psoriatic Arthritis
Korean Post-marketing Surveillance for Xeljanz
The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.
- Trial name
- NCT02984020
- Where
- 49 sites in South Korea
- Volunteers
- 1,041 people
- Sponsor
- Pfizer
Neuropathic Pain
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
The objective of this investigation is to evaluate the safety and efficacy of long term use with Lyrica in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Lyrica will…
- Trial name
- RAINBOW-L (NCT01279850)
- Testing
- Pregabalin (Lyrica) capsule
- Volunteers
- 891 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
HIV Infection
Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.
- Trial name
- NCT01389310
- Where
- 9 sites in Belgium, Germany and 5 more
- Volunteers
- 249 people
- Sponsor
- Bristol-Myers Squibb
Influenza (Healthy Volunteers)
Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the…
- Trial name
- NCT05078060
- Testing
- Quadrivalent Influenza Vaccine, High-Dose Quadrivalent Influenza Vaccine
- Where
- 15 sites in Finland, Germany
- Volunteers
- 1,804 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Degenerative Disc Disease
Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012.
- Trial name
- NCT02429908
- Testing
- TM-Ardis Interbody
- Where
- 10 sites in Belgium, Canada and 4 more
- Volunteers
- 80 people
- Sponsor
- Zimmer Biomet
Intracranial Aneurysms
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up.
- Trial name
- LVIS PAS (NCT05453240)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Microvention-Terumo, Inc.
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