Clinical trials: Guided Surgery
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
Surgery, Gastric Cancer
Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation
By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided.
- Trial name
- NCT05039333
- Testing
- RUS(TM) software : surgical navigation
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Hutom Corp
Hypersensitivity Reactions
Post-market Safety Study of LUMISIGHT
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with…
- Trial name
- NCT07572162
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Kidney Neoplasm, Nephrectomy
Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability
This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy.
- Conditions
- Kidney Neoplasm, Nephrectomy, Surgical Navigation Systems, Renal Mass
- Trial name
- HTK_002 (NCT06945640)
- Testing
- RUS NE
- Where
- South Korea
- Volunteers
- 80 people
- Sponsor
- Hutom Corp
Bone Metastases
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
- Trial name
- NCT00981578
- Testing
- ExAblate 2100
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- InSightec
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
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
Brain Tumor
MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors
The purpose of this study is to evaluate the safety of MRI-guided focused ultrasound thermal ablation of brain tumors performed through intact human skull using the ExAblate transcranial system.
- Trial name
- NCT00147056
- Testing
- ExAblate transcranial system
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- InSightec
Bone Metastases
MR Guided Focused Ultrasound Surgery in the Treatment of Pain From Bone Tumors w/ the ExAblate 2000 Strappable System
A Feasibility Study To Evaluate the Safety and initial Effectiveness of MR guided Focused Ultrasound Surgery in the Treatment of pain resulting from Metastatic Bone Tumors with the ExAblate 2000 strappable system.
- Trial name
- BM005 (NCT03547557)
- Testing
- Exablate 2000 strappable system
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- InSightec
Leiomyoma
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre…
- Trial name
- NCT00131365
- Testing
- ExAblate 2000
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InSightec
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants…
- Conditions
- Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction, Postoperative Delirium
- Trial name
- BrainProtect (NCT07872982)
- Testing
- BrainProtect System, Standard perioperative management
- Where
- 4 sites in United States, Austria and 2 more
- Volunteers
- 304 people
- Sponsor
- Scienceforbrain, UAB
Breast Fibroadenoma
MR Guided Focused Ultrasound Surgery in the Treatment of Breast Fibroadenomas
The primary objective of this pivotal study is to evaluate the safety and efficacy of FUS treatment of breast fibroadenomas. Our hypothesis is that FUS lesion ablation of a fibroadenoma will have the following results: a.
- Trial name
- NCT00147108
- Testing
- ExAblate 2000
- Where
- 5 sites in United States, Japan
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- InSightec
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
CT-guided Minimally Invasive Procedures e.g., Biopsies
Evaluation of the Safety, Effectiveness & Usability of the XACT Robotic System for Image Guided Percutaneous Procedures
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite…
- Trial name
- NCT03008603
- Testing
- XACT Robotic System
- Where
- 2 sites in United States, Israel
- Volunteers
- 60 people
- Sponsor
- Xact Robotics Ltd.
Guided Bone Regeneration
Measurement of the Performance and Safety of RTR+Membrane in Guided Tissue Regeneration (GTR) in Dental Surgical Procedures
The goal of this observational study is to measure in real practice the performance and safety of RTR+Membrane, a synthetic dental membrane for guided tissue regeneration in periodontal or dental implant surgery.
- Trial name
- ObsR+ (NCT06467630)
- Testing
- Preserving alveolar bone volume after tooth extraction, Alveolar crest reconstruction, Covering bone defects during immediate implant placement.
- Where
- 9 sites in France
- Volunteers
- 90 people
- Sponsor
- Septodont
Breast Cancer
Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
Non-randomized, Single Arm Clinical study to Evaluate the Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas
- Trial name
- NCT02794558
- Testing
- ExAblate MRgFUS
- Where
- Japan
- Volunteers
- 91 people
- Sponsor
- InSightec
Tremor, Essential Tremor
ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) for Treatment of Tremor
A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Tremor
- Trial name
- NCT01932463
- Testing
- ExAblate Transcranial System
- Where
- Canada
- Volunteers
- 6 people
- Sponsor
- InSightec
Degenerative Spine Disease, Spondylolisthesis
MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a…
- Conditions
- Degenerative Spine Disease, Spondylolisthesis, Spondylosis
- Trial name
- NCT02057744
- Where
- 9 sites in United States
- Volunteers
- 600 people
- Sponsor
- Mazor Robotics
Bone Resorption, Dental Diseases
Allogeneic Bone Paste Versus Allogeneic Bone Powder
Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation.
- Trial name
- NCT04141215
- Testing
- BIOBank bone paste, BIOBank cortico-cancellous bone powder
- Where
- France
- Volunteers
- 86 people
- Sponsor
- Biobank
Spinal Stenosis, Lumbar Region, Spondylolisthesis
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults.
- Trial name
- NCT03968965
- Testing
- 3D MvIGS Spine Navigation, 2D Fluoroscopy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- 7D Surgical Inc.