Clinical trials: Surgical Performance
Rheumatoid Arthritis, Osteoarthritis
A Single Centre Study to Assess the Long-term Performance of the DePuy ASR™ System in Primary Hip Resurfacing Surgery
The purpose of this study is to monitor the performance and determine the metal ion release of the DePuy ASR™ System in the treatment of patients with hip joint disease requiring hip resurfacing surgery.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders
- Trial name
- NCT00872794
- Testing
- DePuy ASR™ Hip System
- Where
- South Africa
- Volunteers
- 50 people
- Sponsor
- DePuy International
Bone Regeneration
Performance and Safety of Lyoplant® in Guided Bone Regeneration (GBR) in Oral Surgery
Guided Bone Regeneration (GBR) is a well-established surgical technique that employs barrier membranes to ensure the stability of bone augmentation material while preventing the infiltration of soft tissue, thereby facilitating…
- Trial name
- LyOral (NCT06732167)
- Testing
- GBR Lyoplant, GBR Bio-Gide
- Where
- 2 sites in Spain
- Volunteers
- 68 people
- Sponsor
- Aesculap AG
Laparotomy, Incisional Hernia
Clinical Performance and Safety of Suture-TOOL
The goal of this single arm intervention study is to investigate the safety and performance of a suturing device for closure of the midline incision after open abdominal surgery.
- Conditions
- Laparotomy, Incisional Hernia, Wound Infection, Closure Technique
- Trial name
- NCT05695157
- Testing
- Suture-TOOL
- Where
- Sweden
- Volunteers
- 38 people
- Sponsor
- Suturion AB
Off Pump Coronary Artery Bypass Surgery
Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study
This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery.
- Trial name
- NCT07286890
- Testing
- Vacuum Stabilizer System, Vacuum Positioner System, Blower/Mister
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Maquet Cardiovascular
Rhinosinusitis Chronic, Wound Healing
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.
- Conditions
- Rhinosinusitis Chronic, Wound Healing, Sinus Surgery, Mometasone Furoate
- Trial name
- ENHANCE (NCT06642116)
- Testing
- OCEAN
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Polyganics BV
Chronic Low Back Pain, Lumbar Degenerative Disc Disease
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients…
- Trial name
- DISCERN (NCT00949936)
- Testing
- CAdisc™-L (Total Disc Replacement)
- Where
- 4 sites in Belgium, Germany and 2 more
- Sponsor
- Ranier Technology Limited
Orthopedics
Collecting Orthopedic Safety and Performance Data Using Surgeons Clinical Outcomes Registry (SCOR)
The Surgeons Clinical Outcomes Registry (SCOR) is a global registry designed to collect safety and performance data on commercially available Wright Medical products.
- Trial name
- SCOR (NCT04032444)
- Where
- 7 sites in United States
- Volunteers
- 723 people
- Sponsor
- Stryker Trauma and Extremities
Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury
OSsIRIS Study - A Post-market Clinical Follow-up Investigation.
This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in…
- Trial name
- OSsIRIS (NCT06156904)
- Testing
- Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 135 people
- Sponsor
- GreenBone Ortho S.p.A.
Breast Tissue Accessory, Breast Cancer
Motiva Flora Tissue Expander PMCF
The Motiva Flora® Tissue Expander clinical study (hereafter Motiva Flora® TE study) is a 6-month, open-label, prospective, multicentre post-marketing follow-up study designed to confirm the Safety and Effectiveness/Performance of…
- Trial name
- NCT05447988
- Testing
- Breast Tissue Expander
- Where
- 5 sites in Chile, Costa Rica and 2 more
- Volunteers
- 136 people
- Sponsor
- Establishment Labs
Glaucoma, Open Angle Glaucoma
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.
- Trial name
- NCT04773106
- Testing
- ARGOS-SC suprachoroidal pressure sensor
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 22 people
- Sponsor
- Implandata Ophthalmic Products GmbH
Aortic Aneurysm, Aortic Dissection
Thoraflex™ Hybrid IDE Study
The study will assess the effectiveness, safety and clinical outcomes of the Thoraflex™ Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta, with or without involvement of…
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Rupture
- Trial name
- NCT02724072
- Testing
- Thoraflex™ Hybrid Device
- Where
- 12 sites in United States
- Volunteers
- 84 people
- Sponsor
- Bolton Medical
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
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
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
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
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.