Clinical trials: Implants
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
First Degree AV Block
Restoration of Atrioventricular Synchrony Trial
The objective of the trial is to observe the effects of restoring atrioventricular (AV) synchrony in subjects with prolonged PR intervals.
- Trial name
- RESTORE-AV (NCT01275833)
- Testing
- Cardiac resynchronization therapy-defibrillator
- Volunteers
- 2 people
- Sponsor
- Boston Scientific Corporation
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Registry Study of Clinical Application of MRI Compatible CIED
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Trial name
- NCT02380300
- Volunteers
- 2,067 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Hearing Loss
Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)
This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the…
- Trial name
- NCT04279236
- Testing
- Abbreviated Profile Hearing Aid Benefit (APHAB), Glasgow Benefit Inventory (GBI), Additional follow-up visit
- Where
- 8 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- Oticon Medical
Refractory Glaucoma
PAUL® Glaucoma Implant Safety and Effectiveness Study
This prospective, multicenter clinical study is designed to evaluate the safety and effectiveness of the PAUL® Glaucoma Implant in adult patients with refractory glaucoma.
- Trial name
- NCT07907055
- Testing
- PAUL® Glaucoma Implant
- Volunteers
- 65 people
- Sponsor
- Clinical Research Consultants, Inc.
Alveolar Bone Loss, Alveolar Ridge Pathology | Gingiva | Dental
Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation
The study aim is to compare the effectiveness of two bone substitutes, the gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene and xemogenic deproteinized bone matrix, mixed with…
- Trial name
- NCT04511689
- Testing
- gene-activated bone substitute mixed with autobone
- Where
- Russia
- Volunteers
- 24 people
- Sponsor
- Histograft Co., Ltd.
Kyphoplasty, Vertebroplasty
A Prospective, Single-center, Observational Clinical Outcomes Study for Vertebral Compression Fractures Treated With the OsteoPearl Biological Allograft Implants
The primary objective of this observational study is to evaluate fracture stability through longitudinal assessment of subject-reported pain following treatment with the OsteoPearl Biological Allograft in men and women aged ≥50…
- Conditions
- Kyphoplasty, Vertebroplasty, Vertebral Compression Fracture, Allograft
- Trial name
- PEARL ONE (NCT07561489)
- Testing
- Allograft
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Lenoss Medical
Pelvic Organ Prolapse
Post-market Clinical Follow-up of the SRS Implant
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
- Trial name
- NCT05170074
- Where
- 6 sites in Germany
- Volunteers
- 97 people
- Sponsor
- pfm medical gmbh
Jaw, Edentulous, Jaw, Edentulous, Partially
Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
The objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
- Trial name
- NCT00901017
- Testing
- Straumann BoneCeramic, Bio-Oss
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- Institut Straumann AG
Presbyopia
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.
- Trial name
- NCT01166568
- Testing
- PresVIEW Scleral Implants
- Where
- 14 sites in United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- VisDura, Inc.
Complication, Prosthesis Durability
SEBBIN Round, Anatomical and Biconvex Gluteal Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device.
- Trial name
- NCT05062733
- Where
- 2 sites in Italy, Netherlands
- Volunteers
- 60 people
- Sponsor
- Groupe SEBBIN
Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Trial name
- NCT05253976
- Where
- Switzerland
- Sponsor
- Zimmer Biomet
Degenerative Lumbar Spinal Stenosis
Evaluation of the Efficacy and Safety of the FACET FIXation Implant.
This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.
- Trial name
- FACETFIX (NCT05645497)
- Testing
- Surgery with FACET FIXATION implants, Surgery with Pedicle Screw
- Where
- France
- Volunteers
- 116 people
- Sponsor
- SC Medica
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Oral Surgery, Tooth Extraction
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients
- Conditions
- Oral Surgery, Tooth Extraction, Dental Implants
- Trial name
- MUCODA (NCT04390620)
- Testing
- Mucosal Closure
- Where
- 2 sites in Germany, Spain
- Volunteers
- 105 people
- Sponsor
- Aesculap AG
Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis
Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SYMBOL range of medical devices.
- Conditions
- Degenerative Hip Joint Disease, Post-traumatic Osteoarthritis, Hip Arthritis, Femoral Neck Fractures
- Trial name
- NCT05227924
- Testing
- Total hip arthroplasty (primary or revision)
- Where
- 9 sites in France
- Volunteers
- 747 people
- Sponsor
- Dedienne Sante S.A.S.
Schizophrenia
Safety and Tolerability of Risperidone Implants
A one year, open-label, study to evaluate the safety and tolerability of risperidone implants as a maintenance treatment in patients with schizophrenia
- Trial name
- NCT02773576
- Testing
- Risperidone implant
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- Braeburn Pharmaceuticals
Shoulder Injuries, Knee Injuries
SportsPro: Post-Market Clinical Follow Up Study
Retrospective, multi-center, chart review (only to include data that is part of the surgeons' standard practice)
- Conditions
- Shoulder Injuries, Knee Injuries, Hip Injuries
- Trial name
- NCT06320925
- Testing
- Standard of Care Treatment
- Where
- 3 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Stryker Endoscopy
Heart Failure, Mitral Regurgitation
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
- Trial name
- PTOLEMY (NCT00571610)
- Testing
- PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
- Where
- Canada
- Volunteers
- 5 people
- Sponsor
- Viacor
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