Clinical trials: Medical Device, open to volunteers
Generalized Anxiety Disorder (GAD)
Device for Treating Generalized Anxiety
The goal of this clinical trial is to learn if treatment with the BTL-699-2 device (non-invasive repetitive transcranial magnetic stimulation) can decrease anxiety symptoms in adults (aged 22 years and older) diagnosed with…
- Trial name
- NCT07819773
- Testing
- EXOMIND (BTL-699-2) Active treatment
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- BTL Industries Ltd.
Cataract Surgery
Pilot Study: Feasibility and Usability of a Head-Mounted Spatial Computing Device for Intraoperative Visualization During Intraocular Surgery
To evaluate the feasibility and usability of Apple Vision Pro as an adjunct visualization and information display tool during ophthalmic surgery.
- Trial name
- NCT07825337
- Testing
- Apple Vision Pro Visualization System
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Eric Rosenberg
Bone Regeneration, Safety Issues
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as…
- Trial name
- NCT06383377
- Testing
- Tooth extraction and bone graft procedure
- Where
- 5 sites in Belgium
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Wishbone SA
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
- Conditions
- Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction
- Trial name
- NCT06311331
- Testing
- Total Talus Replacement (TTR)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Restor3D
Uncontrolled Hypertension
Netrod-Pilot Study of Renal Denervation With NetrodTM Sixelectrode Radiofrequency RDN System
This single-arm, non-randomized, open-label investigation aims to collect safety and efficacy data of the CE-Marked Netrod™ RDN System in treating European patients with primary hypertension in the absence of anti-hypertensive…
- Trial name
- NCT07061054
- Testing
- Netrod™ six-electrode radiofrequency renal denervation system
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Shanghai Golden Leaf MedTec Co. Ltd
Heart Diseases, ASD - Atrial Septal Defect
Abbott Structural Heart Device Registry
The Abbott Structural Heart (SH) Registry is being conducted to confirm the safety and performance of Abbott's SH devices in a post-market, real-world setting.
- Conditions
- Heart Diseases, ASD - Atrial Septal Defect, VSD - Muscular Ventricular Septal Defect, PFO - Patent Foramen Ovale
- Trial name
- SH-Registry (NCT06590467)
- Testing
- Amplatzer™ Occlusion Devices, Epic™ Surgical Tissue Heart Valve devices
- Where
- 36 sites in United States, Denmark and 8 more
- Volunteers
- 2,500 people
- Sponsor
- Abbott Medical Devices
Alzheimer s Disease, MCI Conversion to Dementia
Development of a Home Test for Measuring Blood P-tau217 in Alzheimer's Disease Using the Tasso Lancet Device
This study compares p-tau217 concentrations in blood collected via the Tasso device versus standard venipuncture in subjects with and without Alzheimer's disease, including a subset with confirmed amyloid pathology.
- Conditions
- Alzheimer s Disease, MCI Conversion to Dementia, pTau217, Biomarkers
- Trial name
- NCT07701161
- Where
- 5 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Neurogen Biomarking LLC
Healthy Volunteers, Rectal Cancer Patients
To Evaluate Dose and Safety of NanoEcho Particle-1 Using NanoEcho Imaging Device Examinations of Rectal Lymph Nodes in Healthy Volunteers and Rectal Cancer Patients.
Clinical nodal staging for rectal cancer tumours in early stages, is today shown to be unreliable and no precise or accurate methods exist.
- Trial name
- NCT06693375
- Testing
- Iron oxide nanoparticles, Rectal Magnetomotoric ultrasound (MMUS)
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- NanoEcho AB
GERD (Gastroesophageal Reflux Disease), NERD
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
The goal of this randomized, double-blind, single-center clinical trial RELEIF is to learn if medical devices work to decrease symptoms of gastroesophageal reflux disease (GERD) in adults' patients.
- Conditions
- GERD (Gastroesophageal Reflux Disease), NERD, Heartburn, Regurgitation, Gastric
- Trial name
- RELIEF (NCT07624383)
- Testing
- Esophageal barrier medical device
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Cellmedis
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Knee Osteoarthritis
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured…
- Trial name
- NCT06627673
- Testing
- Total Knee Arthroplasty
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Maxx Orthopedics Inc
Fracture Arm, Fracture Leg
Accuro XV Ultrasound Imaging System for BoneEnhance and Fracture Detection Algorithms
The Accuro XV is a cart-based, bedside ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone and soft-tissue imaging.
- Conditions
- Fracture Arm, Fracture Leg, Wrist Injury, Ankle Injury
- Trial name
- NCT07853768
- Testing
- Accuro XV Ultrasound Imaging System
- Where
- 10 sites in United States
- Volunteers
- 25,000 people
- Sponsor
- Rivanna Medical, Inc.
Plaque Type Psorisis, Non-pustular Palmoplantar Psoriasis
Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while…
- Trial name
- PASI (NCT07545902)
- Testing
- PROXERA PSOMED 20 cream; PROXERA PSOMED 40 gel
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- ICIM International S.r.l.
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Vaginal Stenosis, Radiation Therapy
Feasibility of Hyivy Device Post-Radiation for Pelvic Malignancies
Vaginal dilator therapy (VDT) with static dilators is often prescribed to patients following vaginal or pelvic radiation therapy.
- Conditions
- Vaginal Stenosis, Radiation Therapy, Cancer, Pelvic Pain
- Trial name
- NCT05648253
- Testing
- Hyivy Intravaginal Device
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Hyivy Health Inc
Acne Scars, Acne Scars - Atrophic
Safety and Efficacy Evaluation of the Radiofrequency Therapeutic Device for the Treatment of Atrophic Acne Scars
The objective of this clinical trial is to evaluate the safety and effectiveness of a radiofrequency treatment device for the treatment of atrophic acne scars.
- Conditions
- Acne Scars, Acne Scars - Atrophic, Acne Scar, Acne Scarring
- Trial name
- NCT07620769
- Testing
- Investigational Device with the function deactivated, Investigational Device with the function activated, Control Device
- Where
- 4 sites in China
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- CLASSYS Inc.
Sleep Apnea Syndromes
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care.
- Trial name
- SESAME (NCT06578390)
- Testing
- Apneal device
- Where
- 11 sites in France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Mitral
Myopia
Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People
The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism.
- Trial name
- MDSW_DiVA2Rx (NCT07297810)
- Testing
- Optical correction values obtained with investigational device and visual acuity, Optical correction values obtained with an autorefractometer and visual acuity, Optical correction values obtained with a phoropter and visual acuity
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Essilor International
Heart Diseases
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP)…
- Trial name
- NCT05174442
- Where
- 36 sites in Germany, Turkey (Türkiye)
- Volunteers
- 685 people
- Sponsor
- Occlutech International AB
Rheumatoid Arthritis
ConsideRAte Study - Splenic Stimulation for RA
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and…
- Trial name
- NCT05003310
- Testing
- Active Stimulation, Baricitinib, Background Treatment
- Where
- 14 sites in United States, Netherlands
- Volunteers
- 28 people
- Sponsor
- Galvani Bioelectronics