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Hemostasis clinical trials

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NCT ID: NCT03896061 Completed - Hemostasis Clinical Trials

A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy

Start date: April 15, 2019
Phase:
Study type: Observational

Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.

NCT ID: NCT03873181 Completed - Hemostasis Clinical Trials

Post-Market Evaluation of HEMOBLASTâ„¢ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery

NOBLE-Laparo
Start date: May 16, 2019
Phase:
Study type: Observational

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLASTâ„¢ Bellows in laparoscopic abdominal, gynecological, and urological surgery.

NCT ID: NCT03711916 Completed - Breast Cancer Clinical Trials

Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery

Start date: March 17, 2017
Phase: N/A
Study type: Interventional

Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection device. Thus, low thermal devices would improve flap perfusion by decreasing the thermal injury resulted by the dissection. Looking into the use of low thermal devices in cases of mastectomy and immediate breast reconstruction has not been documented. The aim of this study is to determine if there are clinical flap perfusion, surgical site drainage, and pain scores differences between mastectomy flaps created using low thermal dissection device and those done with the standard care of Bovie cautery in order to warrant a formal study.

NCT ID: NCT03654560 Completed - Bleeding Clinical Trials

Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting

Start date: December 28, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.

NCT ID: NCT02780869 Completed - Hemostasis Clinical Trials

HEMOBLAST Pivotal Clinical Investigation

Start date: July 18, 2016
Phase: N/A
Study type: Interventional

The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLASTâ„¢ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.

NCT ID: NCT02583854 Completed - Hemostasis Clinical Trials

Comparison Study of Compression Devices Used in Transradial Coronary Angiography

Start date: September 2015
Phase: N/A
Study type: Interventional

The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis. Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications. The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.

NCT ID: NCT02502019 Completed - Hemostasis Clinical Trials

HEMOBLAST Pilot Clinical Investigation

Start date: August 2015
Phase: Phase 1
Study type: Interventional

The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLASTâ„¢ Bellows in abdominal and orthopedic lower extremity surgeries.

NCT ID: NCT02034799 Completed - Hemostasis Clinical Trials

Phase IV Bioseal Study in Brain Tumor Surgery

Start date: November 1, 2013
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT02014402 Completed - Hemostasis Clinical Trials

Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Open Surgeries

Start date: December 2013
Phase: Phase 2
Study type: Interventional

This purpose of this clinical trial is to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal open surgical procedures. Approximately 180 subjects will be treated with either Topical Thrombin (Human) Grifols (120 subjects) or Bovine Thrombin JMI® (60 subjects). Subjects will be evaluated for identification of a target bleeding site (TBS) in which control of bleeding by standard surgical techniques is ineffective or impractical and requires an additional treatment to stop the bleeding. The Investigator (surgeon) will rate the intensity of bleeding at the TBS. Topical Thrombin (Human) Grifols or Bovine Thrombin JMI will then be applied to the TBS and the amount of bleeding at the TBS will be examined.

NCT ID: NCT01388491 Completed - Hemostasis Clinical Trials

A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women

Start date: October 31, 2011
Phase: Phase 2
Study type: Interventional

This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.