Clinical trials: C.Surgical Procedure
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Oral Surgical Procedures
Plenum® Osshp in Maxillary Sinus Elevation Surgery
The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of…
- Trial name
- NCT06136143
- Testing
- Group 1: Autogenous bone graft, Group 2: Plenum® Osshp, Group 3: Plenum® Osshp; + i-PRF
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- M3 Health
Oral Surgical Procedures
Retrospective Observational Study of Implant-supported Restorations With Dental Implants.
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft).
- Trial name
- NCT06154057
- Testing
- Dental Implants installed in an grafted area (sinus lifting), Dental Implants installed in an grafted area (ridge augmentation), Dental Implants installed in an grafted area (extraction sites)
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- M3 Health
Surgical Procedure, Unspecified, Intensive Care Units (ICUs)
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - in hospital and at-home, in patients undergoing…
- Trial name
- NCT06638073
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Surgery, Orthognathic Surgery
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
- Conditions
- Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures
- Trial name
- NCT05073757
- Testing
- Custom-made guides and plates
- Where
- 4 sites in Belgium, France
- Volunteers
- 56 people
- Sponsor
- Global D
Surgical Procedures, Operative
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach…
- Trial name
- NCT07744568
- Testing
- ETHICON™ 4000 Stapler System, Standard of Care Stapler and Reloads
- Volunteers
- 300 people
- Sponsor
- Ethicon Endo-Surgery
Robotic Surgical Procedures in Pediatric Urology
Versius Paediatrics Study
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device)…
- Trial name
- NCT06539442
- Testing
- Versius Surgical System
- Where
- 3 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- CMR Surgical Ltd
Reconstructive Surgical Procedures
A Retrospective Assessment of OviTex PRS (OviTex)
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast…
- Trial name
- PRS (NCT05736848)
- Testing
- OviTex® PRS
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tela Bio Inc
Minimally Invasive Surgical Procedures, Laparoscopy
Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery.
- Conditions
- Minimally Invasive Surgical Procedures, Laparoscopy, Leakage of Cardiac Device
- Trial name
- RELAP (NCT05363813)
- Testing
- M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System)
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 245 people
- Sponsor
- Microline Surgical, Inc.
Pediatric Surgical Procedures, Adult Surgical Procedures
A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures
The main purpose of this study is to demonstrate acceptable performance and assess safety of the HARMONIC 700 Shears device in a post-market setting when used per the instructions for use in pediatric and adult surgical…
- Conditions
- Pediatric Surgical Procedures, Adult Surgical Procedures, Adult Gynecological Procedures, Adult Urological Procedures
- Trial name
- NCT06608485
- Testing
- HARMONIC 700 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 173 people
- Sponsor
- Ethicon Endo-Surgery
Intensive Care Unit, Coronary Artery Bypass Grafting (CABG)
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy. A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight…
- Conditions
- Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass
- Trial name
- MODIFY CSX (NCT06279793)
- Testing
- Fish Oil, Intravenous 0.9% Sodium Chloride
- Where
- 10 sites in Germany
- Volunteers
- 550 people
- Sponsor
- GCP-Service International West GmbH
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.
Mandibular Fractures, Mandible Fracture
Facial iD Customized Mandible Reconstruction Plates
A retrospective post market follow up to confirm the safety and performance of Stryker's Customized Plates for Mandibular Reconstruction.
- Conditions
- Mandibular Fractures, Mandible Fracture, Mandible; Deformity, MANDIBLE
- Trial name
- NCT07245758
- Testing
- Mandibular reconstruction
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Stryker Craniomaxillofacial
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
Elective Surgical Procedures
Evaluation of Non-Invasive Assessment for Post RFAL Procedure Monitoring Using the Nanowear Wearable Multiple Sensor Vest
The objective of this study is to evaluate an experience of post-operative monitoring using the Nanowear wearable multiple sensor vest in plastic surgery
- Trial name
- NCT04721405
- Testing
- Observational Study: No intervention
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Nanowear Inc.
Knee Arthroplasty, Total, Robotic Surgical Procedures
ROSA® Knee System V1.5 Pilot Study
This pilot study seeks to evaluate the initial safety and usability of new features for the ROSA® Knee System, v1.5 and plan design modifications as needed. The primary objectives will be assessed by measuring: 1.
- Conditions
- Knee Arthroplasty, Total, Robotic Surgical Procedures, Joint Diseases, Knee Osteoarthritis
- Trial name
- NCT07009912
- Testing
- Total Knee Arthroplasty
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
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
Reconstructive Surgical Procedures, Plastic Surgery
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 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 GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Trial name
- IMED-GLOW800 (NCT07164040)
- Testing
- The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
- Where
- 3 sites in Portugal, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
Medtronic Signia SDR Product Surveillance Registry
The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic…
- Trial name
- NCT05095935
- Testing
- N/A observational registry
- Where
- 14 sites in United States
- Volunteers
- 430 people
- Sponsor
- Medtronic
Laparoscopic Gynecological Surgical Procedures
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
- Trial name
- NCT06572163
- Testing
- Eximis CS (Contained Segmentation) System
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Eximis Surgical