Clinical trials: Medical Device
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Thoracic Diseases
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine…
- Trial name
- SURPASS (NCT03286400)
- Testing
- CTAG Device with ACTIVE CONTROL
- Where
- 20 sites in France, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- W.L.Gore & Associates
Wrinkle Reduction
Pivotal Study of the Cutera truSculpt Radiofrequency Device for Wrinkle Reduction
The purpose of this pivotal investigation is to evaluate the safety and efficacy of the Cutera truSculpt™ radiofrequency (RF) Device for Wrinkle Reduction.
- Trial name
- NCT03285581
- Testing
- truSculpt RF
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Migraine
Acute Treatment of Migraine With e-TNS
The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients.
- Trial name
- ACME (NCT02590939)
- Testing
- CEFALY Active
- Where
- 3 sites in United States
- Volunteers
- 106 people
- Sponsor
- Cefaly Technology
Cervical Cancer
Feasibility Study of the Xoft® Axxent® Electronic Brachytherapy System for the Treatment of Cervical Cancer
The purpose of this study is to evaluate the safety, performance and usability of the Xoft Axxent Electronic Brachytherapy System and Cervical Applicator as incorporated into the physician's current standard treatment practice…
- Trial name
- NCT01851772
- Testing
- Treatment with Electronic Brachytherapy
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Xoft, Inc.
Fecal Incontinence
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
- Trial name
- TRANSFORM (NCT01090739)
- Testing
- TOPAS Treatment for Fecal Incontinence
- Where
- 14 sites in United States
- Volunteers
- 207 people
- Sponsor
- ASTORA Women's Health
Cataract
DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus
A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful…
- Trial name
- NCT00712244
- Testing
- DisCoVisc, DuoVisc, Healon5
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Alcon Research
Stroke
Ipsihand Device Use in Stroke Patients to Assess Functional Motor Outcomes
This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis.
- Trial name
- NCT04338971
- Testing
- IpsiHand Therapy
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Neurolutions, Inc.
Tibial Delayed Healing
Tibial Delayed Healing Pivotal Clinical Trial
Evaluate the INFUSE/MASTERGRAFT™ Delayed Healing Device as an alternative/replacement to autograft in the treatment of tibial delayed healing.
- Trial name
- NCT01016067
- Testing
- INFUSE/MASTERGRAFT, Autograft bone
- Where
- 16 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Medtronic Spinal and Biologics
Urge Incontinence
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI).
- Trial name
- ESSENCE (NCT05882318)
- Testing
- eCoin Peripheral Neurostimulator System
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Valencia Technologies Corporation
Elective Cardiac Surgery
CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery
Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
- Trial name
- REFRESH II-AKI (NCT03384875)
- Testing
- CytoSorb
- Where
- 20 sites in United States
- Volunteers
- 186 people
- Sponsor
- CytoSorbents, Inc
Infiltration of Peripheral IV Therapy
ivWatch Sensor: Device Validation for Infiltrated Tissues
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT04064229
- Testing
- ivWatch Model 400 with SmartTouch Sensor, ivWatch Model 400 with Fiber Optic Sensor
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
Asthma
Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma
This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed…
- Trial name
- NCT04589663
- Testing
- Mometasone furoate, QMF149, Standard of Care (Soc)
- Where
- 3 sites in Hungary, South Africa
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Nasal Obstruction
Treatment of Nasal Airway Obstruction Using the Aerin Medical Device
Evaluation of the Aerin Medical Device used for the treatment of nasal obstruction.
- Trial name
- NCT02914236
- Testing
- Vivaer Stylus
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Aerin Medical
Ileostomy - Stoma, Colostomy Stoma
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
The study investigates the performance of a new adhesive with regard to the skin condition
- Trial name
- NCT03770078
- Testing
- Test Product A
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 23 people
- Sponsor
- Coloplast A/S
Unresectable Stage III NSCLC
Mobile Devices to Detect Early Pneumonitis in Stage III NSCLC Patients on Durvalumab.
A study of whether mobile devices can improve the detection of pulmonary AEs (including pneumonitis) in stage III NSCLC patients post-CRT, while on durvalumab.
- Trial name
- ON TRAX (NCT04381494)
- Testing
- Multiparametric Mobile Technology
- Where
- 18 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Obesity
Vestibular Stimulation to Trigger Adipose Loss (VeSTAL) Clinical Trial
A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), combined with a lifestyle modification program, compared to a sham control and a lifestyle modification…
- Trial name
- VeSTAL (NCT03640286)
- Testing
- VeSTAL
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 241 people, healthy volunteers welcome
- Sponsor
- Neurovalens Ltd.
Cellulite
A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite
Cellulite is the rippling or dimpling of the skin most commonly located on the thighs and buttocks of women. Its appearance and texture are often likened to that of "cottage cheese" or an orange peel.
- Trial name
- NCT05730335
- Testing
- Rapid Acoustic Pulse
- Where
- 4 sites in United States
- Volunteers
- 59 people
- Sponsor
- Zeltiq Aesthetics
Hepatitis B
A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants
This is an open-label, randomized study to investigate subcutaneous (SC) bepirovirsen when delivered via SC injection from vial or Prefilled syringe fitted with a Safety syringe device (PFS SSD) in healthy adult participants.
- Trial name
- NCT06058390
- Testing
- Bepirovirsen
- Where
- 2 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline