Clinical trials: Surgical Performance
Leg Ulcer, Diabetic Foot Ulcer
Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice
This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e.
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer, Surgical Wound
- Trial name
- GELFI (NCT05148390)
- Testing
- Cutimed® Gelling Fiber
- Where
- Germany
- Volunteers
- 36 people
- Sponsor
- BSN Medical GmbH
Refractive Error, Glaucoma
A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.
- Conditions
- Refractive Error, Glaucoma, Cataracts, Clear Lens Exchange
- Trial name
- NCT05394324
- Testing
- Intervention
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 1,674 people
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
Diaphragm Pacing
Clinical Study to Investigate Safety and Performance of TransLoc Electrodes in Patients Undergoing Surgical Procedures
Feasibility study to advance the development of NeuRx Diaphragm Pacing System (DPS) for the intended use of stimulating the diaphragm to provide respiratory assistance in patients at risk of prolonged mechanical ventilation in…
- Trial name
- NCT02410798
- Testing
- TransLoc electrode
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Synapse Biomedical
Inguinal Hernia
PMCF Study of LiquiBand FIX8® OHMF Device
Study to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
- Trial name
- LBF8-Open (NCT04059640)
- Testing
- LiquiBand FIX8 Open Hernia Mesh Fixation Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 109 people
- Sponsor
- Advanced Medical Solutions Ltd.
Adiposity
Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS).
- Trial name
- BARGASTRO (NCT05433688)
- Testing
- Robotic assisted gastric bypass surgery
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- Aesculap AG
Incision, Surgical, Surgical Incision
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14…
- Conditions
- Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent
- Trial name
- ASOLO-SCI (NCT04894604)
- Testing
- Avance® Solo NPWT System
- Volunteers
- 34 people
- Sponsor
- Molnlycke Health Care AB
Breast Cancer
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in…
- Trial name
- NCT06461663
- Testing
- Breast Cancer Locator Guided Breast Conserving Surgery
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 35 people
- Sponsor
- CairnSurgical, Inc.
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
- Trial name
- NOBLE-Laparo (NCT03873181)
- Testing
- HEMOBLAST™ Bellows
- Where
- 8 sites in Austria, France and 1 more
- Volunteers
- 102 people
- Sponsor
- Biom'Up France SAS
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Study Measuring the Effects of Patient Data for Total Hip and Total Knee Arthroplasty Patients Using an APP Based Sensor for Home Exercise Performance Before and After Operation
Multicenter, Prospective, Randomized, Comparative Study Measuring the Effects on Clinical Outcomes, Patient Satisfaction, Costs and Benefits of Combined Pre-, Intra- and Postoperative Patient Data for THA and TKA Patients Using…
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Clinical Outcome, Patient Satisfaction
- Trial name
- ORTHOPATH (NCT05182320)
- Testing
- OrthoPath, Control
- Where
- 2 sites in Germany
- Sponsor
- Aesculap AG
Cataract, Presbyopia Correction
Visual Quality and Performance of Eyes With Asqelio™ EDoF Toric Lenses
This study evaluates the optical quality and clinical performance of the Asqelio™ EDOF Toric intraocular lens (IOL) in patients undergoing cataract surgery or refractive lensectomy.
- Trial name
- NCT06707545
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- AST Products, Inc.
Coronary Heart Disease, Multi Vessel Coronary Artery Disease
Optilene® Suture for Coronary Artery Bypass Graft Surgery
The study is a voluntary study, initiated by B. Braun to collect clinical data for Optilene® suture concerning its key indication.
- Trial name
- OPTICABG (NCT02546557)
- Testing
- Coronary Artery Bypass Graft surgery
- Where
- 4 sites in Germany, Italy and 2 more
- Volunteers
- 245 people
- Sponsor
- Aesculap AG
Endotracheal Intubation During Surgery, Hospital Acquired Infections
BIP ETT Clinical Tolerability, Safety and Performance Study
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.
- Trial name
- BIPETT (NCT01682486)
- Testing
- BIP ETT (Bactiguard), Standard ETT
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Bactiguard AB
Pancreatectomy, Hepatic Resection
Safety and Performance of a Synthetic Tissue Sealant in Reducing Fluid Leakage in Hepatobiliary and Pancreatic Surgery
Polyganics BV (Groningen, The Netherlands), in close collaboration with University Hospital-Eppendorf (UKE) Hamburg, has developed the Sealing Device for use in hepato-pancreato-bilary (HPB) surgery to reduce leakage of fluids…
- Trial name
- SHIELDS (NCT04024956)
- Testing
- Sealing Device
- Where
- 2 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Polyganics BV
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
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.)
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