Clinical trials: Hemostasis, Surgical
Spinal Tumor, Spinal Injury
Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery.
- Conditions
- Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis
- Trial name
- NCT07354178
- Testing
- CollaStat®, Floseal®
- Where
- 3 sites in South Korea
- Volunteers
- 130 people
- Sponsor
- DALIM TISSEN Co., Ltd.
Hemostasis
Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
- Trial name
- NCT04471350
- Testing
- HEMOBLAST™ Bellows
- Where
- France
- Sponsor
- Biom'Up France SAS
Hemostasis
HEMOBLAST Pivotal Clinical Investigation
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
- Trial name
- NCT02780869
- Testing
- HEMOBLAST Bellows, Absorbable gelatin sponge, USP with thrombin
- Where
- 17 sites in United States
- Volunteers
- 258 people
- Sponsor
- Biom'Up France SAS
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
- Trial name
- NOBLE-Open (NCT03873168)
- Testing
- HEMOBLAST™ Bellows
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 64 people
- Sponsor
- Biom'Up France SAS
Blood Loss, Surgical
Observational Cohort Study of TachoSil (TC-018-IN)
The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.
- Trial name
- NCT00285623
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Nycomed
Hemostasis, Liver Surgery
Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection
This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres.
- Trial name
- ESSCALIVER (NCT00918619)
- Testing
- Sangustop, Tachosil
- Where
- 8 sites in Austria, Germany
- Volunteers
- 128 people
- Sponsor
- Aesculap AG
Hemorrhage
The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when…
- Trial name
- NCT03783039
- Testing
- SURGICEL Powder, SURGICEL Original
- Where
- 6 sites in China
- Volunteers
- 234 people
- Sponsor
- Ethicon, LLC
Hemostatic Techniques, Nephrectomy
Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of…
- Trial name
- Fleece (NCT00598130)
- Testing
- Fleece
- Where
- 4 sites in Israel
- Volunteers
- 30 people
- Sponsor
- OMRIX Biopharmaceuticals
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Knee Replacement Surgery, Osteoarthritis
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
- Trial name
- NCT01410240
- Testing
- Standard of Care, FLOSEAL Hemostatic Matrix + Standard of care
- Where
- 12 sites in United States
- Volunteers
- 137 people
- Sponsor
- Baxter Healthcare Corporation
Bleeding
ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.
- Trial name
- NCT02264730
- Testing
- ClotFoam
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Biomedica Management Corporation
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
Intraoperative Bleeding, Hemorrhage, Surgical
GATT-Patch Versus TachoSil in Liver Surgery
This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with…
- Conditions
- Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
- Trial name
- NCT05385952
- Testing
- GATT-Patch (currently named ETHIZIA), TachoSil
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 132 people
- Sponsor
- GATT Technologies BV
Blood Loss, Surgical, Coagulation Disorder
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that…
- Trial name
- EQUILIBRIX-S (NCT07288489)
- Testing
- Reltodecacog alfa, Usual Pharmacological Care
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 800 people
- Sponsor
- VarmX B.V.
Blood Loss, Surgical
Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and…
- Trial name
- NCT03152461
- Testing
- Quantra System
- Where
- 4 sites in United States
- Volunteers
- 302 people
- Sponsor
- HemoSonics LLC
Soft Tissue Bleeding
The Severe Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic…
- Trial name
- NCT00977925
- Testing
- Fibrin Pad, Standard of Care
- Where
- 17 sites in Australia, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Ethicon, Inc.
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Cardiac Surgical Procedures, Hemorrhage
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery
The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular…
- Trial name
- NCT01639833
- Testing
- Veriset Hemostatic Patch, TachoSil®
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 90 people
- Sponsor
- Medtronic - MITG
Hemostasis, Meningioma Surgery
Phase IV Bioseal Study in Brain Tumor Surgery
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.
- Trial name
- NCT02034799
- Testing
- Bioseal Fibrin Sealant, Standard of Care (SoC)
- Where
- 7 sites in China
- Volunteers
- 256 people
- Sponsor
- Ethicon, Inc.
Blood Loss, Surgical
Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
- Trial name
- NCT00307515
- Testing
- Fibrin Sealant 2 (FS2), Oxidized Regenerated Cellulose (Surgicel)
- Where
- 16 sites in United States
- Volunteers
- 135 people
- Sponsor
- Ethicon, Inc.