Clinical trials: Surgical Performance
Shoulder, Rotator Cuff Disease
Which is the Most Reliable Radiologic Examination for the Diagnosis of Rotator Cuff Tendon Tear?
At this point in time the approach to the diagnosis of rotator cuff tendon tears is not consensual. The French surgeons, considering they have a good experience of this method, preferably use a shoulder CT-arthrography.
- Trial name
- COIFFE (NCT00925366)
- Testing
- Imaging Procedure
- Where
- France
- Volunteers
- 64 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Colorectal Cancer
Effect of EPA on Aerobic Performance, Muscle, and Quality of Life in Colorectal Cancer Surgery Patients
Primary Aim is to test the Hypothesis: Nutritional supplementation with 960mg EPA three times a day positively affects muscle function and mass (assessed by muscle biopsies, assays of cellular aerobic function and DEXA scan) and…
- Trial name
- EPA-colo (NCT01320319)
- Testing
- Experimental: Nutritional Supplementation with EPA
- Where
- United Kingdom
- Volunteers
- 70 people
- Sponsor
- University of Nottingham
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 4 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Arthroplasty, Replacement
To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04849884
- Testing
- CORI™ KNEE TENSIONER
- Where
- 4 sites in United States
- Volunteers
- 77 people
- Sponsor
- Smith & Nephew, Inc.
Orthopedic Surgery, Soft Tissue Approximation
MonoPlus® in Orthopedic Surgery
Single-center postmarket clinical follow-up study (PMCF) on the performance and safety of MonoPlus® in patients undergoing orthopedic surgery
- Trial name
- UNITE (NCT05257278)
- Testing
- MonoPlus®
- Where
- Spain
- Volunteers
- 140 people
- Sponsor
- Aesculap AG
Educational Problems, Surgery
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Owing to coronavirus disease-related social distancing requirements, online education has gained prominence. Surgical trainers consider online videos as a useful teaching aid that maximizes trainees' learning and skill…
- Conditions
- Educational Problems, Surgery, LAP, GYN Disorders
- Trial name
- AA-GYNLAP (NCT05227430)
- Testing
- Educational video tutorials
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves
PRIMO Post-Market Clinical Follow Up Study
Post Market Clinical Follow up Study aimed to collect clinical data on safety and efficacy of Robotically Assisted System called Symani to perform microsurgery techniques such as anastomosis, suturing and ligation for open…
- Conditions
- Open Surgery, Blood Vessels, Lymphatic Ducts and Nerves, Free Flaps
- Trial name
- PRIMO (NCT04843436)
- Testing
- Symani Surgical System
- Where
- 10 sites in Austria, Belgium and 5 more
- Volunteers
- 427 people
- Sponsor
- MMI (Medical Microinstruments, Inc.)
Postoperative Cognitive Dysfunction
Palmitoylethanolamide/Luteolin Supplementation in Older Adults Undergoing Cardiac Surgery
Postoperative Cognitive Dysfunction (POCD) is a common complication after surgery, particularly among older adults. It is characterized by cognitive impairment, reduced functional independence, and decreased quality of life.
- Trial name
- NCT07681063
- Testing
- co-ultramicronized Palmitoylethanolamide + Luteolin (700 mg + 70 mg in 10 ml), Standard of Care
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Fondazione IRCCS San Gerardo dei Tintori
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma 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/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
Tooth, Impacted, Teeth Impact
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.
- Conditions
- Tooth, Impacted, Teeth Impact, Tooth Impaction, Mucosal Wound
- Trial name
- SILKOS (NCT05296902)
- Testing
- Mucosal Closure
- Where
- Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Aortic Valve Regurgitation, Aortic Root Aneurysm
Clinical Evaluation of the Free Margin Cusp Sizer (CALIBRATE)
The objective of this study is to investigate safety and performance of the Free Margin Cusp sizer. The device will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin…
- Trial name
- CALIBRATE (NCT04797572)
- Testing
- Free Margin Cusp Sizer
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Lung Cancer
Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation).
- Trial name
- AB1MALTISC-UK (NCT06869122)
- Testing
- Ablation
- Where
- 2 sites in Italy, United Kingdom
- Volunteers
- 18 people
- Sponsor
- Creo Medical Limited
Postoperative Delirium, Postoperative Recovery in Elderly Patients
Recovery After Upper Extrimety Surgery
The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or…
- Conditions
- Postoperative Delirium, Postoperative Recovery in Elderly Patients, Postoperative Cognitive Dysfunction (POCD)
- Trial name
- Recovery (NCT07714928)
- Testing
- BIS-Guided General Anesthesia, Clinically Guided General Anesthesia
- Where
- Sweden
- Volunteers
- 112 people
- Sponsor
- Region Örebro County
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis
The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile
- Trial name
- VIVALL (NCT03287856)
- Testing
- Transcatheter Aortic Valve Implantation (TAVI)
- Where
- 5 sites in Germany
- Volunteers
- 30 people
- Sponsor
- NVT GmbH
Diseased or Occluded Blood Vessels, Arteriovenous Shunting for Blood Access
LeMaitre LifeSpan® ePTFE Vascular Graft Retrospective Registry
This is a post-market, single-arm, retrospective registry. The investigator or its representative will identify eligible patients through a medical record search.
- Trial name
- NCT04620889
- Testing
- AV Access, PVP
- Where
- Germany
- Volunteers
- 153 people
- Sponsor
- LeMaitre Vascular
Surgical Wound, Trauma-related Wound
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management…
- Trial name
- MATILDA (NCT05632276)
- Testing
- ConvaFoam
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- ConvaTec Inc.
Dry Eye
Evaluation of the Performance of MAF-1217 on Cataract Surgery
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED…
- Trial name
- NCT03833908
- Testing
- MAF-1217
- Where
- 2 sites in Italy
- Volunteers
- 46 people
- Sponsor
- VISUfarma SpA
Vertebral Fracture, Compression Fracture
Spine Bone Cements Outcomes - Post Market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all…
- Conditions
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- Trial name
- NCT06367582
- Testing
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Where
- 12 sites in France, Portugal and 2 more
- Volunteers
- 500 people
- Sponsor
- Teknimed