Clinical trials: Surgical Procedures, Operative
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Surgical Hemostasis
Study of Recombinant Human Thrombin for Bleeding During Surgery
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.
- Trial name
- NCT00245336
- Testing
- rThrombin, bovine thrombin
- Where
- 29 sites in United States
- Volunteers
- 401 people
- Sponsor
- ZymoGenetics
Cardiac Surgical Procedures, Extracorporeal Circulation; Complications
Acute Kidney Injury After Cardiac Surgery
PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1.
- Conditions
- Cardiac Surgical Procedures, Extracorporeal Circulation; Complications, Acute Kidney Injury
- Trial name
- NCT04293744
- Testing
- Colloid priming solution for ECC circuit, Standard priming solution for ECC circuit
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- XVIVO Perfusion
Bowel Preparation Prior to Endoscopic, Radiological and Other Examinations as Well as to Surgical Procedures Which Require Empty Bowel.
Evaluation of the Efficacy, Safety and Tolerance of Experimental Morning-only MOVIPREP® Bowel Preparation in Comparison With Split-dose With Nocturnal Pause MOVIPREP® Bowel Preparation
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
- Trial name
- NCT01732692
- Testing
- MOVIPREP
- Where
- 3 sites in Kazakhstan, Russia
- Volunteers
- 140 people
- Sponsor
- Takeda
Atrial Fibrillation
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and…
- Trial name
- NCT00950092
- Testing
- Numeris-AF Tethered Coagulation System with VisiTrax
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- nContact Surgical Inc.
Surgical Operation, Edentulous Jaw
Multicentric Observational Study Confirming the Performance and Safety of the Axiom® BL X3 Implants
This Post-Market Clinical Follow-Up study aims to document the success and survival of the Axiom® BL X3 Implants up to 3 years after loading.
- Conditions
- Surgical Operation, Edentulous Jaw, Edentulous Mouth, Implant
- Trial name
- Prospective_X3 (NCT05768295)
- Testing
- Axiom BL X3
- Where
- 13 sites in France
- Volunteers
- 200 people
- Sponsor
- Anthogyr
Transforaminal Lumbar Interbody Fusion Surgery
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery.
- Trial name
- NCT06204900
- Testing
- Nerve Cuff and Retractor System
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Retropsoas Technologies, LLC
Bacterial Reduction on Skin Flora Post-product Application
In-vivo Efficacy Study of Patient Pre-operative Preps
The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
- Trial name
- NCT01968707
- Testing
- ChloraPrep Hi-Lite Orange, Normal saline, 3M CHG/IPA Prep Tint 10.5-mL
- Where
- United States
- Volunteers
- 426 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
Pain, Postoperative, Bunion
Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy
This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high…
- Trial name
- NCT04826328
- Testing
- FX301, Normal Saline
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pulmonary Surgical Procedures
Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection
This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung resection.
- Trial name
- NCT03417687
- Testing
- 129Xe MRI, 133 Xe scintigraphy
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Polarean, Inc.
Tibia Fracture Non Union Bone
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a…
- Trial name
- NCT00726193
- Testing
- OsteoGen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Zimmer Biomet
Glioblastoma, Adult
Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma
This protocol has a 2-part design: This phase 2 study is an open-label, multicenter, dose-escalation and expansion study to assess the safety, tolerability, recommended phase 2 dose (RP2D), pharmacokinetics (PK) and clinical…
- Trial name
- NCT03522298
- Testing
- Paxalisib (GDC-0084)
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Kazia Therapeutics Limited
Peri-implantitis
Reconstruction of Peri-implant Osseous Defects: A Randomized Trial
The purpose of this randomized trial was to compare reconstructive surgery of advanced peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap debridement (OFD/Control) in a non-submerged…
- Trial name
- NCT02406001
- Testing
- Tigran PTG, Surgical intervention
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Tigran Technologies AB
Colorectal Cancer
Eval. of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Total Mesorectal Excision Surgery
The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
- Trial name
- NCT02423174
- Testing
- Total Mesorectal Excision, FMwand Surgical System
- Sponsor
- Domain Surgical, Inc.
Bacterial Infections
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.
- Trial name
- cSSSI (NCT00424190)
- Testing
- IV Vancomycin plus IV Aztreonam, Ceftaroline
- Where
- 52 sites in United States, Argentina and 9 more
- Volunteers
- 698 people
- Sponsor
- Forest Laboratories
Peripheral Post-surgical Neuropathic Pain
AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain
This is a Phase IIa randomized, double-blind, placebo-controlled study. The study objective is to investigate the efficacy and safety of repeat oral dosing of the investigational medicinal product (IMP) AP-325 for the treatment…
- Trial name
- NCT04429919
- Testing
- AP-325
- Where
- 32 sites in Belgium, Czechia and 3 more
- Volunteers
- 99 people
- Sponsor
- Algiax Pharmaceuticals GmbH
Acute Major Bleeding, Reversal of Coagulopathy
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who…
- Trial name
- NCT02281201
- Testing
- BE1116 (Prothrombin Complex Concentrate)
- Where
- 11 sites in Japan
- Volunteers
- 11 people
- Sponsor
- CSL Behring
Fecal Incontinence
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Trial name
- NCT05708612
- Testing
- Medical Device (SimplyFI)
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Morbid Obesity
Surgical Intervention in Bariatric Patients: Excess Weight Loss in the Morbidly Obese Following Gastric Plication
Up to 45 men and women who meet the entry criteria will undergo the gastric plication procedure. The study will assess subject excess weight loss (%EWL) following the study procedure at 1, 3, 6, 12, 18, 24, 30 and 36 months.
- Trial name
- NCT01077193
- Testing
- Gastric Plication
- Where
- 3 sites in United States, Czechia
- Volunteers
- 44 people
- Sponsor
- Ethicon Endo-Surgery