Clinical trials: Surgical Performance
Blood Pressure
Performance Measurement in Cardiac Surgery
This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).
- Trial name
- NCT03785132
- Testing
- Cardiac surgery
- Where
- South Korea
- Volunteers
- 1,300 people
- Sponsor
- Seoul National University Hospital
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Surgical Procedure, Unspecified, Surgical Simulation
Laparoscopic Simulator Training and Its Impact on Surgical Education
The primary goal of this study is to answer whether validated laparoscopic simulators truly affect real time performance in the operating room among Gynecology residents.
- Trial name
- NCT00555243
- Testing
- Laparoscopic Simulation training, Traditional Surgical Education
- Where
- 4 sites in United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Abdomino-pelvic Surgery, Bleeding
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
This research conducted by EMBOBIO SAS is intended for patients with bleeding or at risk of bleeding in the abdominal-pelvic region requiring embolization.
- Conditions
- Abdomino-pelvic Surgery, Bleeding, Embolization
- Trial name
- EMBOBIO-1 (NCT07199348)
- Testing
- Embobio
- Where
- France
- Volunteers
- 45 people
- Sponsor
- Embobio Medical
Anesthesia, Child
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery…
- Trial name
- NCT02240368
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- University of Foggia
Muscle Relaxation
Effect of Tetanus on Neuromuscular Junction Monitor Performance in Pediatric Patients
The objective of this study is to assess the performance of acceleromyography as a method of evaluation of muscle relaxation after application of tetanus stimulation to obtain stability of responses before administration of…
- Trial name
- NCT02498678
- Testing
- Tetanus
- Where
- Brazil
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Primary Open Angle Glaucoma
Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system. This medical device includes a sclerectomy punch and injector assembly.
- Trial name
- NCT07358650
- Testing
- Hexiris Microinvasive Scleral Trephine (MIST)
- Where
- 5 sites in Canada
- Volunteers
- 25 people
- Sponsor
- Hexiris Inc
Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle
Multicentre GMK UNI Anatomical Cementless Study - FR
Unicompartmental Knee Arthroplasty (UKA) is the principal surgical alternative to Total Knee Arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis of the Knee, Avascular Necrosis of the Femoral Condyle, Revision Surgery
- Trial name
- NCT06715917
- Where
- 5 sites in France, Switzerland
- Volunteers
- 249 people
- Sponsor
- Medacta International SA
Staphylococcus Aureus
Evaluation of a Diagnostic Device for Detection of Nasal Staphylococcus Aureus
To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture…
- Trial name
- NCT00406549
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Solventum US LLC
the Efficacy and Performance of the Pediatric I-gel Mask
Application of I-gel Laryngeal Mask Airway in Pediatric Patients
Background The laryngeal mask airway (LMA) is a supraglottic airway device ,which is commonly used to manage children's airways, because it is typically easy to use and can avoid problems specific to tracheal intubation.
- Trial name
- NCT03748589
- Testing
- laryngeal mask airway
- Where
- China
- Volunteers
- 413 people
- Sponsor
- Xian Children's Hospital
Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal
The CUSA Clarity Soft Tissue Removal Study
To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures.
- Trial name
- NCT04298268
- Testing
- CUSA Clarity Ultrasonic Surgical Aspirator System use
- Where
- 5 sites in Germany, Italy
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.
- Trial name
- NOBLE-Open (NCT03873168)
- Testing
- HEMOBLAST™ Bellows
- Where
- 9 sites in Austria, France and 1 more
- Volunteers
- 64 people
- Sponsor
- Biom'Up France SAS
Sensorineural Hearing Loss, Bilateral Hearing Loss
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders
- Trial name
- NCT07081542
- Testing
- IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Heart Failure, Systolic, Robotic Surgery
Cardiac Performance During Steep Trendelenburg Position in Patients Undergoing Robotic Surgery Surgery.
The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery.
- Trial name
- NCT06336746
- Testing
- Esophageal Doppler
- Where
- Sweden
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Karlstad Central Hospital
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.
Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation.
- Trial name
- NCT01664689
- Testing
- Microcoaxial Phacoemulsification
- Where
- India
- Volunteers
- 120 people
- Sponsor
- Iladevi Cataract and IOL Research Center
Gastrointestinal Anastomosis
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT02109991
- Testing
- CG-100 device
- Where
- 8 sites in Belgium, Croatia and 2 more
- Volunteers
- 60 people
- Sponsor
- Colospan Ltd.
Pseudoarthrosis of Bone
SPECT/CT Bone Scan Quantification Surgery
The hypothesis of our study is that SPECT/CT bone scan fixation quantified by SUVMAX on a CZT solid state camera preoperatively would identify good responders to lumbar arthrodesis surgery.
- Trial name
- PERQUAL (NCT05183542)
- Testing
- Bone scan
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Central Hospital, Nancy, France
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA