Clinical trials: Surgical Performance, open to volunteers
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
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
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.
Cataract
Visual Performance of Clareon Vivity and PureSee IOL
This is study to determine the visual performance of patients with age-related cataracts implanted in both eyes with either of two extended depth of focus intraocular lenses, the Clareon Vivity (Alcon Healthcare) or the PureSee…
- Trial name
- PURVI2 (NCT07165197)
- Testing
- Phacoemulsification with implantation of an extended depth of focus intraocular lens
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- OMIQ Research
Degenerative Cervical Spinal Stenosis
A Novel Surgical Criteria for Degenerative Cervical Myelopathy in Chinese Ethnicity
Degenerative Cervical Myelopathy (DCM) is an age-related irreversible degenerative disease predominantly affecting the elderly aged 50 and over.
- Trial name
- NCT06528730
- Testing
- DCM
- Where
- Hong Kong
- Volunteers
- 100 people
- Sponsor
- The University of Hong Kong
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
Sensorineural Hearing Loss, Bilateral Hearing Loss
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders
- Trial name
- NCT07081542
- Testing
- IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
Heart Failure, Systolic, Robotic Surgery
Cardiac Performance During Steep Trendelenburg Position in Patients Undergoing Robotic Surgery Surgery.
The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery.
- Trial name
- NCT06336746
- Testing
- Esophageal Doppler
- Where
- Sweden
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Karlstad Central Hospital
Pseudoarthrosis of Bone
SPECT/CT Bone Scan Quantification Surgery
The hypothesis of our study is that SPECT/CT bone scan fixation quantified by SUVMAX on a CZT solid state camera preoperatively would identify good responders to lumbar arthrodesis surgery.
- Trial name
- PERQUAL (NCT05183542)
- Testing
- Bone scan
- Where
- France
- Volunteers
- 70 people
- Sponsor
- Central Hospital, Nancy, France
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
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
Failed Back Surgery Syndrome, Spinal Cord Stimulation
Return to Work for Persistent Spinal Pain Syndrome Type II Patients
A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized…
- Trial name
- OPERA (NCT05269212)
- Testing
- Usual Care trajectory, A biopsychosocial rehabilitation program
- Where
- 5 sites in Belgium
- Volunteers
- 112 people
- Sponsor
- Moens Maarten
Pancreatic Adenocarcinoma Resectable, Non Metastatic
Evaluation of the Efficacy and Safety of Neoadjuvant Therapy in Patients With Surgically Resectable Pancreatic Adenocarcinoma.
This is an open master platform trial, which includes multi neo-adjuvant treatment trials, multi-center, national. This platform trial evaluates the major pathological response rate (mPR) after surgery.
- Conditions
- Pancreatic Adenocarcinoma Resectable, Non Metastatic, ECOG Performance Status Score of 0 or 1
- Trial name
- POWER (NCT07808567)
- Testing
- GnP, FOLFIRINOX
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
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
- 31 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Cataract, Cataract Surgery
Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL)
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular…
- Conditions
- Cataract, Cataract Surgery, Cataract Bilateral, Cataract (Post-operative Cataract Surgery Follow-up)
- Trial name
- BMVDI (NCT07589894)
- Testing
- Clareon TruPlus IOL
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Colvard Kandavel Eye Center
Congenital Heart Disease, Cardiac Surgery
Exercise Prehabilitation in Congenital Heart Disease
Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD). Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood.
- Trial name
- ACE-CHD (NCT07700459)
- Testing
- Exercise prehabilitation
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
Soft Tissue Surgeries
A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
- Trial name
- MARS (NCT06974955)
- Where
- India
- Volunteers
- 365 people
- Sponsor
- Sudhir Srivastava Innovations Pvt. Ltd.
Bone Defects, Orthopaedic Surgery (30 Minutes or Longer)
Evaluation of the Safety and Performance of the Neocement®
This study aims to collect real-world clinical data to gather information on the performance and safety of the Neocement® when used according to its intended purpose and current clinical applications.
- Trial name
- Neocement01 (NCT06973226)
- Where
- Portugal
- Volunteers
- 80 people
- Sponsor
- Bioceramed
Breast Surgery, Lymph Node Excision
Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are: 1.
- Trial name
- CANOPIN (NCT06950021)
- Testing
- Magnetic seed
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- Sirius Medical Systems B.V.
Spine Surgery
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of…
- Trial name
- NCT06827795
- Testing
- A burr used in spine surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Surgify Medical Oy