Clinical trials: Surgical Performance
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
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
Chronic Sinusitis
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
- Trial name
- S8PK (NCT01894503)
- Testing
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Intersect ENT
Cataract
Post-Implant Performance of the EC-3 IOL
The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted.
- Trial name
- NCT01333345
- Where
- 3 sites in United States, France
- Volunteers
- 100 people
- Sponsor
- Aaren Scientific Inc.
Cerebrospinal Fluid Leak
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural…
- Trial name
- NCT03566602
- Testing
- Dura Sealant Patch
- Where
- 3 sites in Netherlands, Switzerland
- Volunteers
- 40 people
- Sponsor
- Polyganics BV
Myoma
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation
The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove…
- Trial name
- NCT00562471
- Testing
- Adhibit Adhesion Prevention Gel, Standard of Care Comparator
- Where
- 6 sites in Canada, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- Angiotech Pharmaceuticals
Breast Cancer, Neoadjuvant Therapy
Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
- Trial name
- NCT04440982
- Testing
- LUM015, Lum Imaging System
- Where
- 6 sites in United States
- Volunteers
- 98 people
- Sponsor
- Lumicell, Inc.
Foot Diseases
Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP).
- Trial name
- NCT01604070
- Where
- 4 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- eMedtrain Inc.
Mitral Regurgitation, Mitral Insufficiency
5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults
Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in…
- Trial name
- NCT04161079
- Testing
- Medtentia Annuloplasty Ring (MAR)
- Where
- Finland
- Volunteers
- 12 people
- Sponsor
- Medtentia International Ltd Oy
Oral Hemorrhage
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental…
- Trial name
- NCT05171231
- Testing
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Where
- 10 sites in Belgium, France
- Volunteers
- 125 people
- Sponsor
- Septodont
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Arterial Thromboembolism
A PMCF Study to Confirm the Performance and Safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter
A post market clinical study to confirm the performance and safety of the LeMaitre® TufTex Single Lumen Embolectomy Catheter on patients undergoing surgical treatment for the removal of arterial emboli and/or thrombi
- Trial name
- SLC (NCT05386277)
- Testing
- TufTex Single Lumen Embolectomy Catheter
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 112 people
- Sponsor
- LeMaitre Vascular
Sport Surgery
Sport Surgery Products Outcomes - A Post-market Follow-up
Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products.
- Trial name
- NCT06532929
- Testing
- Orthopaedic surgeries (ankle), Orthopaedic surgeries (shoulder), Orthopaedic surgeries (knee)
- Where
- 10 sites in France
- Volunteers
- 390 people
- Sponsor
- Teknimed
Cholecystectomy, Robotic
Post Market Clinical Study to Evaluate the Performance of the Versius Surgical System
The goal of this clinical trial is to learn how the Versius Surgical System, a robotic surgery device, works for gallbladder removal surgery (cholecystectomy) in adults.
- Trial name
- NCT07096856
- Testing
- Robotic assisted cholecystectomy
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- CMR Surgical Ltd