NL-OMON53880
Not yet recruiting
Not Applicable
A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of GATT-Patch Versus TachoSil for Hemostasis During Open Liver Surgery - Safety/efficacy of GATT-Patch vs TachoSil During Open Liver Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GATT Technologies BV
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is scheduled to undergo elective open surgery on the liver;
- •Subject is willing and able to give written informed consent for the clinical
- •investigation participation;
- •Subjects is 22 years of age or older at the time of enrollment; and
- •Subject has been informed of the nature of the clinical investigation.
- •Subject in whom the Investigator is able to identify a target bleeding site
- •at the liver resection plane for which any applicable conventional means for
- •hemostasis (e.g. suture, ligature or cautery) are ineffective or impractical,
- •and the choice is made to use a hemostatic agent to stop the bleeding; and
- •Subject has a target bleeding site with a SBSS of 1, 2, or 3 (e.g. reflecting
Exclusion Criteria
- •The target bleeding site is from a large defect in an artery or vein that
- •requires vascular reconstruction with maintenance of vessel patency;
- •Subject is scheduled to undergo surgery on other organs than the liver and
- •its associated biliary and vascular system;
- •Subject is scheduled to undergo a staged liver surgery procedure (e.g.,
- •Associating Liver Partition and Portal vein ligation for Staged hepatectomy
- •Subject is taking multiple antithrombotic therapies in therapeutic dosage up
- •to the time of surgery, but allowing exclusive use of acetylsalicylic acid;
- •Subject has platelet count \<100 x 109/L, an activated partial thrombin time
- •of \>100s, or international normalized ratio \>2\.5;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS Compared to iStent inject W in Patients with Open-Angle Glaucoma Undergoing Cataract SurgeryNL-OMON56815ELIOS Vision Inc14
Not yet recruiting
Not Applicable
A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional InstrumentatioNL-OMON56814Exactech, Inc.220
Completed
Phase 4
A prospective, multicenter, non-randomized, clinical outcome study of the R3 acetabular System in patients with degenerative hip disease.osteoarthritisreumatoid arthritis1002321310005944NL-OMON47358Smith & Nephew Orthopedics AG50
Not yet recruiting
Not Applicable
A prospective, randomized, multi-centered clinical trial to investigate the effectiveness of the digital therapeutic device 'StroKcare' for speech rehabilitation for people with post-stroke dysarthriaKCT0008505Korea Technology & Information Promotion Agency for SMEs68
Completed
Not Applicable
A multicentre, randomised, controlled, clinical Investigation of a standalone decision support Algorithm for Neonatal Seizure Recognitioconvulsionsfits10039911NL-OMON44340niversity College Cork, National University of Ireland40