Clinical trials: Implant
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Aequalis Resurfacing Head Study
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02444299
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 100 people
- Sponsor
- Stryker Trauma and Extremities
Prostate Cancer, Adenocarcinoma of the Prostate
Study of Histrelin Subdermal Implant in Patients With Prostate Cancer
This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.
- Trial name
- NCT01394263
- Testing
- Histrelin hydrogel implant, Zoladex goserelin implant
- Volunteers
- 59 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Ischemic Stricture of Intestine
Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.
- Trial name
- ImpACT-1 (NCT03733236)
- Testing
- ISS Active Stimulation
- Where
- 2 sites in India
- Volunteers
- 98 people
- Sponsor
- BrainsGate
Chronic Low Back Pain
ReActiv8 for Chronic Low Back Pain (PMCF)
The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.
- Trial name
- ReActiv8-A (NCT01985230)
- Testing
- ReActiv8 Implantable Stimulation System implanted and activated.
- Where
- 15 sites in Australia, Belgium and 1 more
- Volunteers
- 96 people
- Sponsor
- Mainstay Medical
Chronic Sinusitis, Nasal Polyposis
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
- Trial name
- NCT03358329
- Testing
- S8 Sinus Implant
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Amputation
e-OPRA Implant System for Lower Limb Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004.
- Trial name
- NCT03720171
- Testing
- e-OPRA Implant System
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Integrum
Prosthetic Joint Infection
Bacteriophage Therapy in Patients With Prosthetic Joint Infections (PJI)
This is a study designed to evaluate bacteriophage therapy in patients with chronic prosthetic joint infections.
- Trial name
- ACTIVE2 (NCT05269134)
- Testing
- Bacteriophage
- Where
- 10 sites in United States
- Sponsor
- Adaptive Phage Therapeutics, Inc.
Cataracts, Astigmatism
Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)
A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.
- Trial name
- NCT00878839
- Testing
- Toric
- Sponsor
- Alcon Research
Tetraplegia/Tetraparesis, Quadriplegia
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot.
- Conditions
- Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury
- Trial name
- GB-PRIME (NCT07127172)
- Testing
- N1 Implant, R1 Robot
- Where
- 2 sites in United Kingdom
- Volunteers
- 7 people
- Sponsor
- Neuralink Corp
Breast Implant Complication, Breast Implant Shell Defect
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Shell Fissure
This prospective implant-surveillance cohort will evaluate predictors of breast implant shell fissure. Women with aesthetic implants without baseline fissure or rupture will undergo annual clinical and imaging assessment for up…
- Trial name
- NCT07810257
- Testing
- Breast Implant Exposure, Structured Implant Shell Imaging
- Where
- Colombia
- Volunteers
- 3,000 people
- Sponsor
- Research Inc
Prostate Adenocarcinoma
Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is…
- Trial name
- BiolenRT (NCT04943536)
- Testing
- bicalutamide, Stereotactic body radiation therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Alessa Therapeutics Inc.
Refractory Epilepsy
Study to Assess Intracerebroventricular (ICV) Delivery of CT-010 in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
This is a Phase 2 double-blind, randomized, placebo-controlled study to assess the safety and efficacy of ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC) in subjects with focal…
- Trial name
- NCT04153175
- Testing
- ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)
- Where
- 11 sites in Australia, Israel
- Volunteers
- 30 people
- Sponsor
- Cerebral Therapeutics LLC
Breast Augmentation and Breast Reconstruction, Mammaplasty
Clinical Study on Tissue Preservation in Breast Augmentation and Reconstruction
This clinical study aims to evaluate the safety and effectiveness of advanced, minimally invasive techniques for breast augmentation and reconstruction.
- Conditions
- Breast Augmentation and Breast Reconstruction, Mammaplasty, Breast Augmentation, Tissue Preservation
- Trial name
- NCT07623564
- Testing
- Mia Harmonization, Mia Scarless Lift, Mia Reconstruction
- Where
- Costa Rica
- Volunteers
- 60 people
- Sponsor
- Establishment Labs
Fecal Incontinence
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction…
- Trial name
- Fidelia (NCT04976153)
- Testing
- aSMDC
- Where
- 34 sites in Austria, Bulgaria and 10 more
- Volunteers
- 290 people
- Sponsor
- Innovacell GmbH
Glaucoma
VividWhite Glaucoma Implant (VW-51) Pivotal Study
The VividWhite Glaucoma Implant (VW-51) is a novel surgical implant designed to treat glaucoma. This study is a 12-month, 65-participant non-comparative multicentre study to assess the safety and effectiveness of the VW-51…
- Trial name
- NCT06176170
- Testing
- VividWhite Glaucoma Implant (VW-51)
- Where
- 6 sites in Australia
- Volunteers
- 65 people
- Sponsor
- VividWhite Pty Ltd
Repeated IVF Failure
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.
- Trial name
- Thrive-IVF (NCT01864356)
- Testing
- NT100
- Where
- 21 sites in United States
- Volunteers
- 157 people
- Sponsor
- Nora Therapeutics, Inc.
Hearing Loss, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear