N/A N=60 Endostapler Hemostasis Study
Intraoperative Staple Line Bleeding as Measured by the Provided Bleeding Severity Scale
Primary: Staple Line Bleeding — 2.08; 2.57 score on a scale — p=0.01
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=355 Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
Morbid Obesity
Primary: Number of Participants With Postoperative Gastrointestinal Hemorrhage — 13; 39 participants
N/A N=103 SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects
Hemorrhage
Primary: Haemostatic Success at 5 Minutes — 90 Participants
N/A N=27 Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Hemorrhoid
Primary: Uneventful Creation of a Functional Staple Line at First Firing of Device — 27 participants
N/A N=164 Disposable Powered Articulating Linear Cutter Stapler in Total-Thoracoscopic Anatomic Lobectomy (Segmentectomy)
Lung Cancer
Primary: Number of Participants With Anastomosis Success — 79; 83 Participants — p=0.9727
Phase 1 N=27 HEMOBLAST Pilot Clinical Investigation
Hemostasis
Primary: Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators — 0.7754 Kappa statistic
N/A N=240 Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
Gastric Procedures · Lung Resection Procedures
Primary: Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures — 0; 1; 0 Participants
Phase 3 N=721 A Study of Fibrocaps™ in Surgical Bleeding
Mild or Moderate Surgical Bleeding
Primary: Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery — 1.0; 2.5 minutes — p=< 0.0001
N/A N=35 Gastric Tissue Stapler Comparison Study
Gastric Resection
Primary: Pressure Evaluation — 126; 163 mmHg
N/A N=136 A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.
Abdominal Injury · Thoracic Diseases
Primary: The Primary Endpoint is the Number of Subjects Reporting Serious Adverse Device Effects (SADEs), Including Intra- and Post-operative Leaks. — 0; 9 Participants
N/A N=164 Disposable Powered Articulating Linear Cutter Stapler in Gastrointestinal Tissue Cutting and Anastomosis
Gastrointestinal Neoplasm
Primary: Number of Participants With Anastomosis Success — 80; 80 Participants — p=<0.05
N/A N=270 An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Excision of Kidney
Primary: Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions — 0.1359; 0.1836 proportion of transected vessels
N/A N=1,439 Epidemiology of Severe Peroperative Bleeding During Scheduled Surgery
Surgery · Blood Loss
Primary: Unanticipated Bleeding — 0; 100; 0 percentage of participants
N/A N=57 Effectiveness of BoneSeal® on Bone Hemostats in Patients Undergoing Cardiothoracic Surgery
Coronary Artery Bypass Grafting
Primary: Ease of Use — 4; 1 units on a scale
N/A N=60 Endostapler Sleeve Gastrectomy Study
Obesity
Primary: Intraoperative Endoscopic Staple Line Bleeding Score — 1.63; 2.00 score on a scale
N/A N=101 Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
Obesity
Primary: Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups. — 3; 2 Participants
N/A N=66 Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
Endovascular Procedures
Primary: Cohen's Kappa Coefficient (κ) — 0.84 proportion of agreement
N/A N=38 Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery
Colorectal Cancer
Primary: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. — 4 Participants
N/A N=168 A Prospective, Multi-Center Evaluation of the ECHELON CIRCULAR Powered Stapler in Left-Sided Colorectal Anastomoses
Left-sided Colon Resection
Primary: Percentage of Participants With Stapler Performance Issues — 11.9 Percentage of subjects
N/A N=149 Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
Hemorrhoids
Primary: Intraoperative Bleeding — 32; 50 participants — p=0.0001
N/A N=50 ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
Lung Cancer
Primary: Incidence of Prolonged Air Leaks — 5 participants
Phase 4 N=252 The Bioseal Vascular Study
Cardiovascular Bleeding · Vascular Bleeding · Hemorrhage
Primary: Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application. — 96; 88.2 percentage of patients
N/A N=280 An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses
Gastrointestinal Disease · Colorectal Disease
Primary: Time of Surgery (Skin Open to Skin Close) — 168.4; 172.7 minutes — p=0.7774
N/A N=106 Endoscopic vs. Suction Device Calibration in Sleeve Gastrectomy
Gastrectomy · Obesity
Primary: Number of Staple Load Firings — 5.26; 5.42 Number of staples
N/A N=234 The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
Hemorrhage
Primary: Hemostatic Success at 5 Minutes — 109; 103 Participants — p=<0.0001
N/A N=142 Articulating Enseal Versus Ligasure Energy Devices
Task Performance
Primary: Raw Task Load Index (TLX) Score Assigned by Surgeons — 51.7; 32.5 units on a scale — p=0.0001
N/A N=201 Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
Non Small Cell Lung Cancer
Primary: Incidence of Intra-Operative Hemostatic Intervention — 0.0533; 0.0833 Proportion transections w/ intervention
Phase 4 N=150 EVARREST™ Fibrin Sealant Patch Post-Market Study
Hemorrhage · Soft Tissue Bleeding
Primary: Safety Parameter - Incidence of Thromboembolic Events — 2; 7 Participants
N/A N=236 Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Hemostasis · Bleeding
Primary: The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute…
N/A N=30 Tri Staple Technology Stapler Used in Gastric Bypass
Sleep Apnea · Hypertension · Hyperlipidemia
Primary: Proportion of Patients With an Uneventful Creation of a Functional Staple Line — 28 participants