Clinical trials: IMPLANTATION
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
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Observational Prospective Study OPTIMA II - Follow-up
The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA study.
- Trial name
- OPTIMAII (NCT02099565)
- Where
- Russia
- Volunteers
- 572 people
- Sponsor
- AstraZeneca
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT04860765
- Testing
- SAPIEN 3 THV
- Where
- 19 sites in United States
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Aortic Stenosis
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System.
- Trial name
- NCT02950428
- Testing
- ACURATE neo™TA Delivery System
- Where
- 7 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Symetis SA
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.
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
Aortic Stenosis
Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical…
- Trial name
- NCT03043404
- Testing
- Transcatheter aortic valve replacement
- Where
- 2 sites in Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
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.
Mitral Insufficiency, Heart Valve Disease
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
- Conditions
- Mitral Insufficiency, Heart Valve Disease, Cardiovascular Disease, Heart Disease
- Trial name
- NCT02478008
- Testing
- CardiAQ TMVI System (Transapical DS)
- Where
- 9 sites in Denmark, France and 2 more
- Volunteers
- 2 people
- Sponsor
- Edwards Lifesciences
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.
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.
Hearing Loss, Binaural, Cochlear Implantation
Mi2000 TICI - Post-market Implantation Study
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI.
- Trial name
- TUPIS (NCT07897318)
- Testing
- Cochlear Implantation
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Infertility
Barusiban Subcutaneously for Reducing Implantation Failure Due to Uterine Contractions
This trial investigates the effects of FE 200440 compared to placebo on implantation rate in women undergoing IVF/ICSI treatment
- Trial name
- BASIC (NCT01723982)
- Testing
- Barusiban (FE 200440)
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 256 people
- Sponsor
- Ferring Pharmaceuticals
Chronic Sinusitis
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus…
- Trial name
- EXCEED (NCT02228720)
- Testing
- Propel Nova Sinus Implant
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Intersect ENT
Dry Macular Degeneration, Geographic Atrophy
Study of Subretinal Implantation of Human Embryonic Stem Cell-Derived RPE Cells in Advanced Dry AMD
The Phase I/IIa clinical trial is designed to assess the feasibility of delivery and safety of Human Embryonic Stem Cell-Derived RPE Cells on a parylene membrane (CPCB-RPE1) in patients with advanced, dry age-related macular…
- Trial name
- NCT02590692
- Testing
- CPCB-RPE1
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Regenerative Patch Technologies, LLC
Cataract
Visual Outcomes After Cataract Surgery: Multifocal AcrySof® IQ ReSTOR® Intraocular Lenses Versus Monofocal Intraocular Lenses
The purpose of this study is to assess and compare visual outcomes of the AcrySof® IQ ReSTOR® +3.0 D intraocular lens (IOL) to a commercially available monofocal IOL in cataract patients.
- Trial name
- NCT01290068
- Testing
- AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, Monofocal IOL
- Volunteers
- 208 people
- Sponsor
- Alcon Research
Cataract, Presbyopia
Non-Inferiority Study Comparing MINI WELL READY® and FineVision® in Patients With Cataract Surgery
Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
- Trial name
- NCT03060954
- Testing
- MINI WELL READY ®, FINE VISION®
- Where
- 2 sites in France
- Volunteers
- 8 people
- Sponsor
- SIFI SpA
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