Clinical trials: Surveillance
Leadless Pacemaker
Aveir Leadless Pacemaker Japan PMS
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing.
- Trial name
- NCT07106788
- Testing
- Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades
- Where
- 14 sites in Japan
- Volunteers
- 304 people
- Sponsor
- Abbott Medical Devices
Chronic Myeloid Leukemia
Asciminib RMP Study
This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.
- Trial name
- NCT05943522
- Testing
- Asciminib
- Where
- 17 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Novartis Pharmaceuticals
Gastric Neoplasms, Pancreatic Neoplasms
Chromogranin A as Blood Marker in Cancer Patients
Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are a heterogenous group of neoplasms that arise from enterochromaffin cells of the gastrointestinal (GI) tract and pancreas. They account for 50-70% of all incident NETs.
- Conditions
- Gastric Neoplasms, Pancreatic Neoplasms, Small Intestinal Neoplasms, Colorectal Neoplasms
- Trial name
- NCT03817866
- Testing
- BRAHMS CgA II KRYPTOR
- Where
- 4 sites in United States, Germany
- Volunteers
- 175 people
- Sponsor
- Brahms AG
Human Immunodeficiency Virus-Type 1
A Study to Assess the Safety and Effectiveness of Darunavir for Treating Human Immunodeficiency Virus-Type I (HIV-1) Infection in Filipino Patients
The purpose of this study is to assess the safety and effectiveness of darunavir for the treatment human immunodeficiency virus-type I (HIV-1) infection among Filipino adults.
- Trial name
- NCT01726348
- Testing
- No intervention
- Sponsor
- Janssen Pharmaceutica
Patent Ductus Arteriosus
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect…
- Trial name
- NCT04371081
- Testing
- Amplatzer Piccolo Occluder
- Where
- Japan
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Cuff-tear Arthropathy
Anatomical Shoulder™ Inverse/Reverse Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder™ Inverse/Reverse System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02466321
- Testing
- Inverse/Reverse Shoulder Arthroplasty
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 154 people
- Sponsor
- Zimmer, GmbH
Contrast-enhanced MRI With Dotarem
Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine).
- Trial name
- NCT03048006
- Testing
- MRI with Dotarem
- Volunteers
- 44,456 people, healthy volunteers welcome
- Sponsor
- Guerbet
Rhinitis, Allergic, Perennial
Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus
- Trial name
- NCT02238236
- Testing
- Alesion®
- Volunteers
- 3,793 people
- Sponsor
- Boehringer Ingelheim
Safety Outcomes
Safety Of DAPAGLIFLOZIN (FORXIGA) in Patient With Type 2 Diabetes Mellitus (T2dm) In Vietnam From A Post-Marketing Surveillance Program
This study is conducted to meet the requirements of the Drug Administration of Vietnam (DAV) on conducting necessary safety evaluations in routine clinical practice for a new medication within 3 years from its date of approval.
- Trial name
- DAPAPMS (NCT07210307)
- Where
- Vietnam
- Volunteers
- 1,001 people
- Sponsor
- AstraZeneca
Hepatitis C
Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection
This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan.
- Trial name
- NCT02591277
- Testing
- Harvoni
- Where
- 125 sites in Japan
- Volunteers
- 3,294 people
- Sponsor
- Gilead Sciences
Coronary Artery Disease
Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System…
- Trial name
- SAFE-MCS (NCT05077657)
- Testing
- Early Bird® Bleed Monitoring System, Impella®
- Where
- 11 sites in United States
- Volunteers
- 203 people
- Sponsor
- Saranas, Inc.
Peripheral Artery Disease
Prospective, Post Market Surveillance Q3-registry (POLARIS)
This is a prospective, non-randomized post market surveillance registry designed to document the clinical Performance in Routine clinical practice of the POLARIS Peripheral Vascular Self Expanding Stent System
- Trial name
- Q3-Registry (NCT02307292)
- Testing
- POLARIS Peripheral Vascular Self Expanding Stent System
- Where
- Germany
- Volunteers
- 250 people
- Sponsor
- QualiMed Innovative Medizinprodukte GmbH
Over Active Bladder
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder
This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.
- Trial name
- NCT01260311
- Testing
- Fesoterodine
- Where
- 37 sites in Philippines
- Volunteers
- 508 people
- Sponsor
- Pfizer
Intracranial Surgery, Extracranial Surgery
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
The purpose of this study is to confirm clinical safety and performance of Medtronic's NIM Vital™ System and accessories when used as intended in a real-world setting.
- Conditions
- Intracranial Surgery, Extracranial Surgery, Intratemporal Surgery, Extratemporal Surgery
- Trial name
- PSR-ENT (NCT06637995)
- Testing
- Intraoperative Nerve Monitoring
- Where
- Germany
- Volunteers
- 205 people
- Sponsor
- Medtronic
Restless Legs Syndrome
REQUIP RLS Post Marketing Surveillance
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
- Trial name
- REQUIP RLS PMS (NCT01327339)
- Testing
- Ropinirole
- Volunteers
- 755 people
- Sponsor
- GlaxoSmithKline
Pediatric Gastroenteritis
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions.
- Trial name
- NCT01195844
- Testing
- Rotavirus Vaccine
- Volunteers
- 230 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid-related Disorders, Opioid Addiction
Surveillance Monitoring of Opioid Abuse in Poison and Drug Treatment Centers
To conduct surveillance for abuse, misuse, overdose, addiction, and death and to evaluate if the REMS meets its surveillance goals, and if it does not, to modify it appropriately based on the metrics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02871232
- Testing
- Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion
- Volunteers
- 26,500 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Post Market Surveillance Study Following Clinical Routine
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not…
- Trial name
- Rally CRT-P (NCT02488239)
- Testing
- CRT-P indicated patients
- Where
- 8 sites in Finland, Germany
- Volunteers
- 64 people
- Sponsor
- Boston Scientific Corporation
Breast Cancer
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
- Trial name
- NCT01047358
- Testing
- Aromasin
- Where
- 22 sites in South Korea
- Volunteers
- 206 people
- Sponsor
- Pfizer
Total Hip Arthroplasty
A Post Market Surveillance Study About the MONOCER Cup
Over the years, the use of large diameter femoral heads has become increasingly common in orthopaedics due to the decreased risk of dislocation due to increased jumping distance and range of motion.
- Trial name
- NCT05785364
- Testing
- Mpact 3D metal MONOCER cup
- Where
- Switzerland
- Volunteers
- 250 people
- Sponsor
- Medacta International SA
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