Clinical trials: Medical Devices
Obstructive Sleep Apnea
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
- Trial name
- NCT02357706
- Testing
- APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- ResMed
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Cataract
Galilei Lens Professional vs. Predicate Devices: a Comparison Study
Study question: How does the new GALILEI Lens Professional compare to predicate devices? Study hypothesis: The GALILEI Lens Professional achieves a better precision in the postoperative, calculated target refraction with cataract…
- Trial name
- NCT01961089
- Testing
- Galilei Lens Professional, IOLMaster, Lenstar
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ziemer Ophthalmic Systems AG
Chronic Sinusitis
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis
A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
- Trial name
- INTACT (NCT00939471)
- Testing
- Relieva™ Balloon Sinuplasty™ System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Integra LifeSciences Corporation
Alcoholism
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.
- Trial name
- NCT03195894
- Testing
- TripleA
- Volunteers
- 115 people
- Sponsor
- Kontigo Care AB
Wrinkle
Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds
The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.
- Trial name
- PLLA (NCT05215054)
- Testing
- Gana V®, Sculptra®
- Where
- France
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GCS Co., Ltd
Schizophrenia, Mental Disorder
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
- Conditions
- Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02219009
- Testing
- MIND1 System
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pelvic Organ Prolapse
Pelvic Floor Repair Systems for Prolapse Repair
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for…
- Trial name
- PROPEL (NCT00638235)
- Testing
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 725 people
- Sponsor
- ASTORA Women's Health
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Asthma
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device.
- Trial name
- NCT01012739
- Testing
- Indacaterol 150 μg via the Concept1 dry-powder inhaler, Indacaterol 60 μg via the Simoon dry-powder inhaler, Indacaterol 120 μg via the Simoon dry-powder inhaler
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 35 people
- Sponsor
- Novartis Pharmaceuticals
Avascular Necrosis of Hip, Osteoarthritis, Hip
Metasul Monoblock Component™ Cup in a Hip Resurfacing Application With the Durom® Hip Resurfacing Femoral Component
The Zimmer Hip Resurfacing System Post-Market Clinical Follow-up study will examine the safety and efficacy of this device in the young and/or active patient with advanced hip disease.
- Conditions
- Avascular Necrosis of Hip, Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis
- Trial name
- MMC (NCT03681639)
- Testing
- Serum Metal ion levels determined to monitor changes in chromium and cobalt levels
- Where
- Germany
- Volunteers
- 45 people
- Sponsor
- Zimmer Biomet
Cataract
Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery
The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts.
- Trial name
- NCT01069172
- Testing
- FS Laser Surgery, CCC Surgery
- Where
- Dominican Republic
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Optics
Avascular Necrosis, Osteoarthritis, Hip
Allofit® IT With HXPE in Total Hip Arthroplasty
The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary…
- Conditions
- Avascular Necrosis, Osteoarthritis, Hip, Inflammatory Arthritis, Post-Traumatic Osteoarthritis of Hip
- Trial name
- NCT03672929
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 197 people
- Sponsor
- Zimmer Biomet
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
Child, Preschool, Child
Monitoring Activity And Gait In Children
COHORT A: To study whether a digital health tool called Actigraph can be used to collect information on gait and physical activity in healthy children aged 3-17.
- Conditions
- Child, Preschool, Child, Adolescent
- Trial name
- MAGIC (NCT04823650)
- Testing
- COHORT A: Actigraph, Panoramic Bracelet and GENEActiv
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Pfizer
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix
Pulmonary Disease, Chronic Obstructive
A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD)
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).
- Trial name
- NCT03979807
- Testing
- Olodaterol/Tiotropium Bromide, Umeclidinium/ Vilanterol
- Where
- United States
- Volunteers
- 11,296 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer
CairnSurgical Breast Cancer Locator (BCL) Post-Market Study
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in…
- Trial name
- NCT06461663
- Testing
- Breast Cancer Locator Guided Breast Conserving Surgery
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 35 people
- Sponsor
- CairnSurgical, Inc.
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery