Clinical trials: Elective
Leak, Cerebrospinal Fluid
CraniSeal Post Approval Study
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct…
- Trial name
- NCT06406790
- Testing
- CraniSeal, DuraSeal
- Where
- 8 sites in United States
- Volunteers
- 224 people
- Sponsor
- Pramand LLC
Symptomatic Venous Thromboembolism (VTE)
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA).
- Trial name
- ROXI-ASPEN (NCT07213778)
- Testing
- REGN7508, Acetylsalicylic Acid (ASA)
- Where
- 51 sites in United States, Greece and 3 more
- Volunteers
- 2,000 people
- Sponsor
- Regeneron Pharmaceuticals
Iron-Deficiency Anemia, Iron-Deficiency
Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).
Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside…
- Trial name
- Real-CHOICE (NCT04318405)
- Testing
- Iron isomaltoside 1000
- Where
- 21 sites in Switzerland
- Volunteers
- 327 people
- Sponsor
- Pierre Fabre Pharma AG
Elective Cardiac Surgery
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.
- Trial name
- REFRESH (NCT02566525)
- Testing
- CytoSorb
- Where
- 8 sites in United States
- Volunteers
- 52 people
- Sponsor
- CytoSorbents, Inc
Hemophilia
BAY14-2222 Continuous Infusion in Surgeries
Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.
- Trial name
- NCT00606060
- Testing
- Kogenate (BAY14-2222)
- Where
- Israel
- Volunteers
- 15 people
- Sponsor
- Bayer
Acute Pain, Surgery
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring…
- Trial name
- NCT02599870
- Testing
- NeuroIDgenetix Test Panel
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- AltheaDx
Thrombocytopenia Associated With Chronic Liver Disease
A Study to Evaluate the Safety and Efficacy of PN20 in the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
The main aim of this clinical trial is to assess the safety and efficacy of a single dose of PN20 in treatment of thrombocytopenia in adult patients with chronic liver disease undergoing an elective procedure.
- Trial name
- NCT07446491
- Testing
- PN20
- Where
- 8 sites in China
- Volunteers
- 54 people
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
Cardiovascular Disease, Coronary Artery Disease
Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention
Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat patients with obstructive coronary artery disease (CAD).
- Trial name
- X-PLORER (NCT01442792)
- Testing
- UFH, Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939) and UFH
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 108 people
- Sponsor
- Bayer
Thromboembolism
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
- Trial name
- NCT00353678
- Testing
- YM150
- Where
- 79 sites in Austria, Bosnia and Herzegovina and 15 more
- Volunteers
- 1,141 people
- Sponsor
- Astellas Pharma Inc
Elective HFOV for Respiratory Failure in Neonates/Infants, Rescue HFOV in Neonates and/Infants With Refractory Respiratory Failure Under Conventional Therapy
Servo-n HFOV Study: Safety and Performance in Neonates and Infants
The purpose of this study is to evaluate the safety and performance of High-Frequency Oscillatory Ventilation (HFOV) modes of the Servo-n ventilator in neonates and infants, by using a prospective, observational, single-arm…
- Trial name
- NCT06114992
- Testing
- Servo-n HFOV modes
- Where
- 4 sites in France, Poland and 1 more
- Volunteers
- 83 people
- Sponsor
- Maquet Critical Care AB
Cardiac Arrest, Heart Arrest
ICD Shock Detection by a Wearable
Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD
- Conditions
- Cardiac Arrest, Heart Arrest, Cardiopulmonary Arrest
- Trial name
- LOISICD (NCT04565652)
- Testing
- Device Wearers
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Lois Medical LTD
Elective Cranial Procedures With Dural Incision
DuraSeal Sealant Post Market Study
DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as…
- Trial name
- NCT00704340
- Testing
- DuraSeal Dural Sealant System, Standard of Care
- Where
- United States
- Volunteers
- 237 people
- Sponsor
- Integra LifeSciences Corporation
Musculoskeletal Pain
Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants
- Trial name
- NCT03193593
- Testing
- EB-001
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Bonti, Inc.
Hypovolaemia Due to Acute Blood Loss
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.
- Trial name
- PHOENICS (NCT03278548)
- Testing
- Volulyte 6%, Ionolyte
- Where
- 61 sites in Austria, Belgium and 8 more
- Volunteers
- 2,289 people
- Sponsor
- Fresenius Kabi
Scar Prevention
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Trial name
- NCT01037985
- Testing
- EXC 001
- Where
- 6 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Venous Thromboembolism
Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.
- Trial name
- NCT02170935
- Testing
- BIBR 1048 capsule
- Volunteers
- 62 people
- Sponsor
- Boehringer Ingelheim
Arthroplasty, Replacement, Knee
A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery
To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery
- Trial name
- PEARL (NCT00595426)
- Testing
- YM150, Warfarin
- Where
- 54 sites in United States, Canada
- Volunteers
- 685 people
- Sponsor
- Astellas Pharma Inc
Hemostasis, General Surgery
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
- Trial name
- NCT04660721
- Testing
- sFilm-FS, TACHOSIL®
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 33 people
- Sponsor
- Sealantium Medical Ltd.
Elective Cesarean Section, Pain Management
Efficacy and Safety of EXPAREL Versus Standard of Care (SoC) in Subjects Undergoing Elective Cesarean Section
The purpose of this study is to compare total opioid consumption by subjects in different treatment groups. Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction…
- Trial name
- CHOICE (NCT03853694)
- Testing
- 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen, 150 mcg Duramorph + multi-modal pain regimen, Exparel TAP + multi-modal pain regimen
- Where
- 18 sites in United States
- Volunteers
- 167 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG