Clinical trials: Medical Device
Chronic Migraine
Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine
A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients.
- Trial name
- NCT04194008
- Testing
- Nerivio
- Where
- 10 sites in United States
- Volunteers
- 126 people
- Sponsor
- Theranica
Breast Screening
Study of iBreast, a Handheld Device to Detect Breast Abnormalities During Screening Visits for Breast Cancer
This study will test the iBreastExam device to find out whether it can detect a mass or lump in the breast as accurately as a routine breast cancer screening examination.
- Trial name
- NCT04761055
- Testing
- Clinical Breast exam (CBE), iBreastExam device, mammogram
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Tinnitus
Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression
To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha subunit (SCN9) gene in those subjects with…
- Trial name
- NCT01412918
- Testing
- The Inhibitor™ Tinnitus Masking Device
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Medical College of Wisconsin
Disorder of Soft Tissue
Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device
The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as determined by clinical assessment of treatment sites and routine tracking of adverse events.
- Trial name
- NCT01708213
- Testing
- Aline HA
- Where
- 2 sites in Canada
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- TauTona Group
Obstructive Sleep Apnea
AutoSet for Her Quality of Life Clinical Trial
Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female…
- Trial name
- FEM-PAP (NCT02400073)
- Testing
- AutoSet for Her
- Where
- 3 sites in Germany, Spain
- Volunteers
- 122 people
- Sponsor
- ResMed
Degenerative Disc Disease
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease.
- Trial name
- CALIBER (NCT02075554)
- Testing
- CALIBER
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Globus Medical Inc
Femoro Acetabular Impingement, Pain, Postoperative
Outcomes of CPM Usage Following Arthroscopic Acetabular Labral Repair
The purpose of this study is to measure whether CPM (continuous passive motion) usage improves outcomes following arthroscopic hip surgery that includes labral repair.
- Conditions
- Femoro Acetabular Impingement, Pain, Postoperative, Hip Labral Tear
- Trial name
- NCT03407612
- Testing
- Continuous Passive Motion
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Ohio State University
Knee Meniscus Tear
A Prospective, Post-market, Multi-center Feasibility Study of the BioDuct® Meniscal Repair Device
To demonstrate repair of the meniscus at 6 months, as evaluated by MRI, will be observed; and clinical qualitative assessments will improve from preoperative to postoperative time points with the BioDuct® Meniscal Repair Device.
- Trial name
- NCT01270919
- Testing
- BioDuct Meniscal Repair Device
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Stryker Orthopaedics
Cerebral Ischemia
A Prospective Study of a New Device for Monitoring Cerebral Oxygenation on Healthy Volunteers
The purpose of this study is to determine whether a new cerebral oxygen monitoring device is effective and comparatively similar to the current approved devices.
- Trial name
- NCT00598819
- Testing
- CDI 1000 COM
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- University of California, Irvine
Post-Op Complication, Skin Flap Necrosis
Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. ViOptix probes will be secured to the arm and hand.
- Trial name
- NCT05592145
- Testing
- ViOptix
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Treatment for Cellulite on the Stomach and Flanks
Multi-Center Pilot Study of Cutera truSculpt Device
Exploratory study to evaluate the safety, efficacy and ergonomics of Cutera truSculpt device.
- Trial name
- NCT03782545
- Testing
- Cutera truSculpt Device
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Cutera Inc.
Organ Transplant
Trial to Compare the SherpaPak™ Device vs Cold Storage
The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts. There are two methods of organ preservation. The first method is the use of cold storage.
- Trial name
- SherpaPak (NCT05194514)
- Testing
- SherpaPak™ Device, Cold Storage
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Cedars-Sinai Medical Center
Migraine Headache
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)
This study consists of a 4-week screening period, a 24-week treatment period for all participants, followed by a 28-week treatment period extension (to 52 weeks in total) for a subset of at least 60 and up to 80 participants, and…
- Trial name
- NCT03557333
- Testing
- INP104
- Where
- 36 sites in United States
- Volunteers
- 360 people
- Sponsor
- Impel Pharmaceuticals
Rib Fractures, Rib Fracture Multiple
Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma
The purpose of this study is to use the Duracore splinting device to measure lung capacities of patients with rib fractures in control and experimental groups to determine if lung capacities improve with the splint.
- Trial name
- NCT04909463
- Testing
- Chest Splint
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- CommonSpirit Health
Cesarean Section Complications, Post Partum Hemorrhage
DAISY Uterine Drain Device Evaluation
The goal of this study is to obtain user feedback while placing and observing the DAISY uterine drain with wall suction. This study defines the obstetrical surgeons as "users" and the patients in whom the drain is placed as…
- Conditions
- Cesarean Section Complications, Post Partum Hemorrhage, Uterine Atony With Hemorrhage, Uterine Bleeding
- Trial name
- NCT06219538
- Testing
- DAISY Uterine Drain
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Symptomatic Cervical Disc Disease
Performance of the Hedrocel(R) Cervical Fusion Device
The objective of this clinical investigation is to compare patients treated with Anterior Cervical Discectomy and Fusion (ACDF) using the Hedrocel Cervical Fusion Device, with a concurrent, randomized, control group receiving…
- Trial name
- NCT00758758
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- 13 sites in United States
- Volunteers
- 231 people
- Sponsor
- Zimmer Biomet
Device Replacement, Elective Replacement (ERI)
REPLACE: Implantable Cardiac Pulse Generator Replacement Registry
The objective of this study is to prospectively estimate the all-cause complication rates at 6-months for patients undergoing generator replacement due to elective replacement indicator (ERI), advisory, or upgrade without a…
- Conditions
- Device Replacement, Elective Replacement (ERI), Device Advisory, Device Upgrade
- Trial name
- REPLACE (NCT00395447)
- Testing
- Straight-forward Device Replacement, Device Replacement with Upgrade
- Where
- 71 sites in United States
- Volunteers
- 1,744 people
- Sponsor
- Biotronik, Inc.
Sudden Cardiac Death, Bradycardia
REASSURE AV Registry
Long term follow-up to monitor safety for patients implanted with a B301 ASSURE device.
- Trial name
- REASSURE (NCT01074034)
- Testing
- AV Therapy Assessment-B301 investigational device
- Where
- 36 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Scientific Corporation
Stroke, Hand Function
Development of a FES Device for Hand Use During Arm Activities Following Stroke
The goal of the study is to develop an individualized, synergy resistant, portable electromyographic (EMG)-driven functional electrical stimulation (FES) device that allows for Reliable and Intuitive control of hand (ReIn-Hand)…
- Trial name
- NCT03986216
- Testing
- ReIn-Hand device assisted home-based practice
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Northwestern University
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG