Clinical trials: Surgical Performance
Full Thickness Rotator Cuff Tear
Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears
Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears.
- Trial name
- NCT01256242
- Testing
- Augment Rotator Cuff, Standard Suture Repair
- Where
- 4 sites in Canada
- Volunteers
- 31 people
- Sponsor
- BioMimetic Therapeutics
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Coronary Artery Disease, CABG
Clinimetric Properties of Performance Based Functional Outcome Measure After (CABG) Surgery
The purpose of this research is to determine which performance based functional outcome test among Time up and go test, Five times sit to stand test, 2 minute walk test and 6 minute walk test has the greatest significance in…
- Trial name
- NCT07060937
- Testing
- Physiotherapy Protocol
- Where
- 2 sites in Pakistan
- Volunteers
- 100 people
- Sponsor
- Riphah International University
Breast Neoplasms
Sienna+® Injection Time Study 4 Arms
Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery.
- Trial name
- Sentimag02 (NCT02612870)
- Testing
- Sienna+ retro, Sienna+ peri, Sienna+ retro 4-6
- Where
- 2 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- Kantonsspital Baden
Education, Coaching
Structured Remote Surgical Coaching to Improve Operative Performance in Laparoscopic Cholecystectomy
Surgical coaching, defined as a constructive relationship that provides objective feedback to individuals about a broad range of factors influencing operative performance, is a key strategy for integrating adult learning theory…
- Conditions
- Education, Coaching, Surgical, Laparoscopic
- Trial name
- NCT04512560
- Testing
- Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training, Surgical Training using Conventional Training Program
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dr. Boris Zevin
Roux-en-Y Gastric Bypass, Obesity
Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical used in laparoscopic RYGB surgery to create anastomoses.
- Trial name
- NCT03968757
- Testing
- easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Performance and Safety of an Airway Management Device
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating…
- Trial name
- NCT01757977
- Testing
- double lumen endotracheal tube placement and use
- Where
- Ireland
- Volunteers
- 25 people
- Sponsor
- John Laffey
Obesity
Improvement in Physical Performance and Obesity Surgery in Patients Older Than 60 Years
The main objective of this study is to compare the efficacy of two weight losing strategies (obesity surgery with gastric banding, and standard of care) on physical performance in elderly obese persons submitted to a physical…
- Trial name
- ELDSURG (NCT02307942)
- Testing
- Gastric banding
- Where
- 7 sites in France
- Volunteers
- 32 people
- Sponsor
- University Hospital, Toulouse
Acute Mesenteric Ischemia, Sepsis Bacterial
Performance of the SeptiCyte LAB Test for Antibiotic Stewardship in Mesenteric Ischemia
This study will help determine whether the SeptiCyte LAB test can accurately differentiate between SIRS and actual infections in postoperative patients, potentially reducing unnecessary antibiotic use and improving patient…
- Conditions
- Acute Mesenteric Ischemia, Sepsis Bacterial, Intra-abdominal Infection, Digestive Inflammation
- Trial name
- SPASM (NCT06507423)
- Testing
- Septicyte Lab Test pre operative, Septicyte Lab Test post operative
- Where
- France
- Volunteers
- 15 people
- Sponsor
- Central Hospital, Nancy, France
Complications, Outcome
Safety Improvement and Checklist Application
The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery.
- Trial name
- SICA (NCT01343069)
- Testing
- implementation surgical checklist
- Sponsor
- Regional Hospital of Bolzano
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
Failed Back Surgery Syndrome, Spinal Cord Stimulation
Return to Work for Persistent Spinal Pain Syndrome Type II Patients
A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized…
- Trial name
- OPERA (NCT05269212)
- Testing
- Usual Care trajectory, A biopsychosocial rehabilitation program
- Where
- 5 sites in Belgium
- Volunteers
- 112 people
- Sponsor
- Moens Maarten
Anesthesiology Training
A Trial to Determine the Effect of Simulation Based Training on Initial Performance of Ultrasound Guided Axillary Brachial Plexus Blockade in a Clinical Setting
Investigators hypothesize that virtual reality based training offers an additional learning benefit over standard training (using cadaveric dissection and human volunteers) in preparing novice anaesthetists to perform their first…
- Trial name
- NCT01965314
- Testing
- Simulation based training, Traditional training
- Where
- Ireland
- Volunteers
- 10 people
- Sponsor
- Cork University Hospital
Surgical Procedure, Unspecified
Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery
This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery.
- Trial name
- NCT05412914
- Testing
- Remimazolam infusion, Propofol infusion
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Konkuk University Medical Center
Vitrectomy
A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery
This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.
- Trial name
- NCT05689333
- Testing
- Vista Vitrectomy Probe
- Where
- 4 sites in United States
- Volunteers
- 32 people
- Sponsor
- VISTA Ophthalmics
Pancreatic Adenocarcinoma Resectable, Non Metastatic
Evaluation of the Efficacy and Safety of Neoadjuvant Therapy in Patients With Surgically Resectable Pancreatic Adenocarcinoma.
This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.
- Conditions
- Pancreatic Adenocarcinoma Resectable, Non Metastatic, ECOG Performance Status Score of 0 or 1
- Trial name
- POWER (NCT07808567)
- Testing
- GnP, FOLFIRINOX
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Cataract
Cataract Surgery: Femto LDV Z8 Versus Conventional
The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract…
- Trial name
- COMFORT (NCT02351271)
- Testing
- Femto LDV Z8, Manual capsulorhexis&lens fragmentation
- Volunteers
- 130 people
- Sponsor
- Ziemer Ophthalmic Systems AG
Rate of Complete Resection in a Unique Surgical Time
Comparison of Two Bipolar Resector in Less Than 3cm Myoma Resection
Hysteroscopic resection of type 0, 1 or 2 myoma is frequent. The more frequent resector used for myoma resection is 26Fr hysteroscope.
- Trial name
- DIAPER (NCT03402516)
- Testing
- 18.5 resector, 26Fr resector
- Where
- France
- Volunteers
- 308 people
- Sponsor
- Bicetre Hospital
Surgical Videos, Pre-operative Training
Effect of Pre-operative Training Using Surgical Videos on Resident Performance of Unilateral Salpigo-oophrectomy
There is a need for the development and validation of new teaching strategies and resources for surgical training that can occur outside of the operating room.
- Trial name
- NCT03230552
- Testing
- Instructional surgical video
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Unity Health Toronto