Clinical trials: Safety Plan
Fertility, Fertility, Male
Plan A Occlusion and Reversal System Feasibility Study
Prospective, multicenter, single-arm, open label, interventional clinical trial investigating the safety and effectiveness of the Plan A Male Contraceptive System to occlude the vas deferens to block the passage of sperm and then…
- Conditions
- Fertility, Fertility, Male, Healthy Male Adults
- Trial name
- NCT07361120
- Testing
- Occlusion System
- Where
- 3 sites in Australia, Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
Solid Tumor, Colorectal Cancer
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
- Conditions
- Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer, Rectosigmoid Junction Cancer
- Trial name
- NCT05943041
- Testing
- GB104(Level 1), GB104(Level 2), GB104(Level 3)
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- GILongevity
Chronic Myelogenous Leukemia
Safety And Efficacy Of Bosutinib
The objective of this surveillance is to collect information about 1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3.
- Trial name
- BLF (NCT02501330)
- Testing
- Bosutinib
- Volunteers
- 702 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.
Ileus, Gastro-Intestinal Disorder
A Study to Evaluate LB1148 for Return of Bowel Function in Subjects Undergoing Bowel Resection
The purpose of this study is to evaluate the safety and efficacy of LB1148 in subjects undergoing planned bowel resection.
- Trial name
- INTEGRITY (NCT05470387)
- Testing
- LB1148
- Where
- 23 sites in United States
- Volunteers
- 23 people
- Sponsor
- Palisade Bio
Coronary Disease
Study of Otamixaban Versus Unfractionated Heparin (UFH) and Eptifibatide in Non-ST Elevation Acute Coronary Syndrome
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive…
- Trial name
- SEPIA-ACS1 (NCT00317395)
- Testing
- Otamixaban (XRP0673), unfractionated heparin, eptifibatide
- Where
- 36 sites in United States, Argentina and 34 more
- Volunteers
- 3,241 people
- Sponsor
- Sanofi
Infantile Neuroaxonal Dystrophy
A Study to Assess Efficacy and Safety of RT001 in Subjects With Infantile Neuroaxonal Dystrophy
The purpose of this study is to evaluate the efficacy and safety of RT001 in patients with Infantile Neuroaxonal Dystrophy (INAD).
- Trial name
- NCT03570931
- Testing
- RT001
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biojiva LLC
Male Contraception
Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
This is a Phase 1b/2a open-label, dose escalation 3 part-study, 28-day, 90-day or 180 day repeat dose study of YCT-529 in healthy males who have decided to have a vasectomy and are waiting for the procedure and for men who have…
- Trial name
- NCT06542237
- Testing
- YCT-529
- Where
- New Zealand
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- YourChoice Therapeutics, Inc.
Large Hole Percutaneous Arterial Closure
Safety and Performance Study for Arterial Large Hole Vascular Closure Device
To study will assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients…
- Trial name
- ELITE (NCT05951634)
- Testing
- PerQseal ELITE
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Diabetes Mellitus, Type 2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 14332 CL as Tablet in Female and Male Patients With Type 2 Diabetes
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 14332 CL following administration of multiple rising oral doses over 10 days in patients with type 2 diabetes.
- Trial name
- NCT02212925
- Testing
- BI 14332 CL
- Volunteers
- 38 people
- Sponsor
- Boehringer Ingelheim
Percutaneous CFA Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device FIV
The purpose of this Clinical Investigation Plan (CIP) is to: 1. Confirm the safety and performance of the PerQseal® large hole closure system. 2.
- Trial name
- Frontier-IV (NCT03423602)
- Testing
- PerQseal®
- Where
- 11 sites in Germany, Ireland
- Volunteers
- 75 people
- Sponsor
- Vivasure Medical Limited
Large Hole Percutaneous Arterial Closure
Safety and Performance Study of Large Hole Vascular Closure Device - France
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 20 patients in 2 centres within France.
- Trial name
- FRONTIER V (NCT05323877)
- Testing
- Test Device (PerQseal+)
- Volunteers
- 20 people
- Sponsor
- Vivasure Medical Limited
Multiple Myeloma
A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)
The purpose of this original study is to determine the recommended phase 2 dose (RP2D) of TAK-079 when administered to participants with NDMM in combination with the backbone treatment regimen.
- Trial name
- NCT03984097
- Testing
- TAK-079, Lenalidomide, Dexamethasone
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Takeda
18 to 24 F Percutaneous Femoral Arteriotomy Closure
Safety and Performance Study of Large Hole Vascular Closure Device
The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral…
- Trial name
- Frontier-III (NCT02788448)
- Testing
- VIVASURE CLOSURE DEVICE
- Where
- 3 sites in Germany
- Volunteers
- 42 people
- Sponsor
- Vivasure Medical Limited
Glaucoma, Ocular Hypertension
Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice.
- Trial name
- NCT01191008
- Testing
- Latanoprost-timolol maleate fixed combination ophthalmic solution
- Volunteers
- 661 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pneumococcal Infections
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs)…
- Trial name
- PNEU-PLAN (NCT03885934)
- Testing
- V114, Prevnar 13®
- Where
- 26 sites in Finland, Malaysia and 3 more
- Volunteers
- 606 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Safety And Efficacy Of Rescriptor In Patients For Human Immunodeficiency Virus (HIV) Patients
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the Local Product Document (LPD) (unlisted adverse drug reaction), 2) the incidence of adverse drug reactions in this…
- Trial name
- NCT00823966
- Testing
- Rescriptor
- Volunteers
- 3 people
- Sponsor
- Pfizer
Neurosurgery
Post-market Clinical Follow-up Plan of StypCel™ Absorbable Hemostat
This study is a post-market clinical follow-up (PMCF) plan for the StypCel™ Absorbable Hemostat, a medical device used to control bleeding during neurosurgery. The study include 108 patients .
- Trial name
- PMCFStypcel (NCT07199439)
- Where
- Latvia
- Volunteers
- 108 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Skin Laxity
The INFORM Study: Rotational Fractional Resection for Submental Contouring
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.
- Trial name
- NCT03853980
- Testing
- Focal Contouring System
- Where
- 14 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Recros Medica, Inc.
Hepatocellular Carcinoma, Metastatic Liver Cancer
Safety and Effectiveness of BioTraceIO 360 for Planning, Monitoring and Assessment of Liver Tissue Ablation Procedures
Pilot study planned to demonstrate the safety and effectiveness of the use of BioTraceIO 360 for Planning, Monitoring and Assessment of liver tissue ablation procedures Multi-center (up to 5 investigational sites) prospective…
- Trial name
- PANORAMA (NCT05582018)
- Testing
- BioTraceIO 360
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Techsomed Medical Technologies LTD