Clinical trials: Surgical Performance
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Inferior Vena Cava Abnormality, Fluid Responsiveness
Transhepatic Echography for Fluid Responsiveness After Cardiovascular Surgery
Fluid expansion in critically ill patients following high risk surgery may induce fluid overload and worse outcome. Several tools have been developped to predict fluid responsiveness in such situation in order to avoid…
- Conditions
- Inferior Vena Cava Abnormality, Fluid Responsiveness, Fluid Overload, Venous Congestion
- Trial name
- THEFRACS (NCT04914455)
- Testing
- Echocardiography and transhepatic inferior vena cava assessment using ultrasound.
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Lille
Lung Cancer
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of…
- Trial name
- AB1MALTISC (NCT06689488)
- Testing
- Ablation
- Where
- Netherlands
- Volunteers
- 30 people
- Sponsor
- Creo Medical Limited
Pedicle Screw, Surgical Navigation Systems
Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery
Pedicle screw malposition is a common problem for spine surgeons. A poorly placed screw can lead to potentially serious complications (hemorrhage, paralysis) in the short- or medium-term.
- Trial name
- ODYSSEE (NCT05565131)
- Testing
- Guided placement with PYTHEAS® ODYSSEE
- Where
- 2 sites in France
- Volunteers
- 14 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Ophthalmological Virtual Surgery Training
Virtual Surgery: Construction of a Training Program and Analysis of Significant Factors for Operating Performance
Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation where the surgeon requires much training and where there is an increased risk of operative complications in the early stage.
- Trial name
- NCT02559661
- Testing
- Training on a virtual simulator in eye surgery
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Total Hip Replacement, Patient-Reported Outcomes
Patient Scores and Functional Tests After Hip Surgery
This study aims to explore how well patient self-assessments reflect their actual physical performance following hip replacement surgery.
- Trial name
- NCT07048041
- Testing
- Functional Assessment Battery
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Ordu University
Aortic Insufficiency
The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D…
- Trial name
- NCT01732835
- Testing
- HAART 300 Annuloplasty Device
- Where
- 8 sites in Czechia, Germany
- Volunteers
- 68 people
- Sponsor
- Biostable Science & Engineering
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
Dural Defect, Cerebrospinal Fluid Leak
Immiseal™ Dural Sealant Post-Market Registry Study
This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct…
- Conditions
- Dural Defect, Cerebrospinal Fluid Leak, Neurosurgical Procedures
- Trial name
- NCT07651826
- Where
- Latvia
- Volunteers
- 85 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Mitral Regurgitation, Mitral Insufficiency
Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation
The purpose of the trial is to demonstrate the safety and performance of the Medtentia Annuloplasty Ring (MAR) during mitral valve repair surgery.
- Trial name
- NCT01678144
- Testing
- Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Prostate Cancer, Rectal Cancer
Video Analysis of Errors and Technical Performance Within Minimally Invasive Surgery Short Title: Video Analysis in Minimally Invasive Surgery (VAMIS)
Despite the high volumes, advanced minimally invasive surgery is non-standardised and variations often occur in surgical technique, performance, delivery, team communication, and surgical approach.
- Trial name
- VAMIS (NCT05279287)
- Testing
- Video and kinematic data recording of minimally invasive surgical procedure
- Where
- 5 sites in United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The Griffin Institute
Cardiac Surgery Under Extra Corporeal Circulation, Cardiac Surgery Requiring Cardiopulmonary Bypass
Comparison of the Performance and Effectiveness of Two Transfusion-Saving Devices: Cell-Saver and SAME
An observational study comparing two systems of perioperative blood recovery in cardiac surgery, one system allowing red blood cell reinfusion and one system allowing red blood cell and platelet reinfusion.
- Trial name
- SAME-CELL (NCT06766032)
- Testing
- CELL-Saver, SAME
- Where
- France
- Volunteers
- 304 people
- Sponsor
- Nantes University Hospital
Acute Kidney Injury
Diagnostic Performance of Two Tools
Developing new tools for early detection of AKI in open-heart surgeries.
- Trial name
- NCT05268211
- Testing
- urinary oxygen partial pressure
- Volunteers
- 130 people
- Sponsor
- Assiut University
Contusions, Incision
Dermal Wound Closure Using Silkam®
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
- Conditions
- Contusions, Incision, Laceration
- Trial name
- DERMASILK (NCT05225714)
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Aesculap AG
Sarcoma
Bone Arches: Performance of Pseudo-scanner Sequences in Segmenting the Extent of the Tumour and in Planning Surgical Resection Using the CT Scan as a Reference
The goal of this exploratory interventional study aims to evaluate the performance of "pseudo-scanner" MRI sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing…
- Trial name
- SARCOUPE (NCT06988007)
- Testing
- Whole body MRI
- Where
- 2 sites in Belgium
- Volunteers
- 122 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Menopause Surgical
Hormonal Regulation of Cardiometabolic Health Study
The goal of this observational study is to understand how the loss of ovarian function after oophorectomy affects the health and well being of women aged 35-50. The study focuses on four areas: 1.
- Trial name
- HoCa (NCT07406412)
- Testing
- Surgical removal of ovaries, Hormone Replacement Therapy (HRT)
- Where
- 7 sites in Finland
- Volunteers
- 120 people
- Sponsor
- University of Jyvaskyla
Primary Open Angle Glaucoma (POAG)
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
- Trial name
- NCT02434692
- Testing
- ARGOS-IO system
- Where
- 11 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Proximal Femoral Fracture, Dinamic Hip Surgery
Motion Graphic Training for Scrub Nurses in Hip Surgery
This pilot randomized controlled trial evaluates the effect of motion graphic video-based training on the performance of scrub nurse students during dynamic hip screw (DHS) surgery.
- Trial name
- NCT07701564
- Testing
- Motion Graphic Video Training, Routine Clinical Training
- Where
- Iran
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Arak University of Medical Sciences
Rotator Cuff Tears
Shoulder Functional Performance After Shoulder Surgery
Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.
- Trial name
- NCT04388306
- Testing
- Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
- Where
- Turkey (Türkiye)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Abant Izzet Baysal University