Clinical trials: Medical Devices
Medical Devices
BIO|CONCEPT.Renamic Neo Study
The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.
- Trial name
- NCT04350008
- Testing
- Renamic Neo programmer device, including software; PK-222-L ECG cable
- Where
- 8 sites in Australia
- Volunteers
- 110 people
- Sponsor
- Biotronik Australia Pty Ltd.
Transgenderism, Erectile Dysfunction
Sexual Functioning After Erection Prosthesis Placement in Post Phalloplasty Transgender Persons
This study aims to explore sexual satisfaction among transgender men and their partners following the placement of erectile prostheses after phalloplasty.
- Conditions
- Transgenderism, Erectile Dysfunction, Prosthesis Durability, Gender Dysphoria
- Trial name
- NCT06639776
- Testing
- Questionnaire
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- University Hospital, Ghent
Cerumen Impaction, Earwax Impaction
Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands…
- Conditions
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- Trial name
- EAR (NCT07834593)
- Testing
- Unidose cerumenolytic solution, Spray cerumenolytic solution
- Where
- 3 sites in France
- Volunteers
- 80 people
- Sponsor
- Laboratoires Gilbert
Back Pain
Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back Pain
The study will evaluate the clinical efficacy and performance of the BTL-043 and BTL-899 devices for alleviating back pain. It is a prospective, multi-center, open-label, single-arm study.
- Trial name
- NCT07700433
- Testing
- Treatment with BTL-043, BTL-899
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- BTL Industries Ltd.
Heart Failure
Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients
Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy.
- Trial name
- CRT-LVAD (NCT02169076)
- Testing
- Cardiac Resynchronization Therapy
- Where
- United States
- Sponsor
- University of Louisville
Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial…
- Conditions
- Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
- Trial name
- NCT01477008
- Testing
- BiPhasic Cartilage Repair Implant, Marrow Stimulation
- Where
- 11 sites in Taiwan
- Volunteers
- 92 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Femoral Fractures
Observational Retrospective and Prospective Study on the Treatment of Femoral Fractures With EBA2
This is an observational, retrospective and prospective study where subjects who have undergone surgery with EBA2 medical device for lateral proximal femoral fractures will be followed for data collection since the day before…
- Trial name
- NCT01599221
- Testing
- EBA2
- Where
- 3 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Citieffe S.r.l
Acute Respiratory Failure
Prevention of Damage Induced by Facial Mask Ventilation
In patients with acute respiratory failure (ARF) undergoing noninvasive ventilation (NIV), the main complication of the use of the mask is the development of decubitus, sometimes so severe and painful as to force a suspension of…
- Trial name
- 3PROSNIV (NCT01351155)
- Testing
- Skin protective dressing device
- Where
- Italy
- Volunteers
- 252 people
- Sponsor
- Ospedale San Donato
Aging
Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA®
The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking.
- Trial name
- HEBE2 (NCT05609617)
- Testing
- injection, Cream application
- Where
- France
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Laboratoires FILLMED
Device Induced Injury, Necrosis, Pressure
Mucosal Pressure of the Laryngeal Mask Airway Supreme Versus the i-Gel in Paralyzed Anesthetized Female Patients
In the following randomized non-crossover study, the investigators test the hypothesis that directly measured mucosal pressure differ between the laryngeal mask airway (LMA) Supreme and the i-Gel in paralyzed anesthetized…
- Conditions
- Device Induced Injury, Necrosis, Pressure, Complication of Device Insertion, Airway Morbidity
- Trial name
- NCT01367678
- Testing
- Laryngeal Mask Airway Supreme, i-Gel extraglottic airway device
- Where
- 2 sites in Austria, Switzerland
- Volunteers
- 30 people
- Sponsor
- Schulthess Klinik
Obstructive Sleep Apnea
Skiin-PSG Sleep Apnea
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the…
- Trial name
- NCT06247878
- Testing
- Skiin underwear chest band
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
Patient Ventilator Interactions
Analysis and Evaluation of Asynchronies Between NIV Patients and Their Prisma VENT or LUISA Ventilator
This study aims to analyze the types, rates, and patterns of disturbances between the breathing of patients receiving non-invasive ventilation and their ventilator (patient-ventilator asynchronies, PVA) during routine therapy…
- Trial name
- NCT07768748
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Löwenstein Medical Technology GmbH & Co. KG
Hemoglobins
Non-invasive Measurement of Hemoglobin in Infants and Neonates
Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg.
- Trial name
- NCT02655107
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- University Hospital Schleswig-Holstein
Ultrasound
Learning Outcomes With Point-of-Care Ultrasound
Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility.
- Trial name
- NCT04021693
- Testing
- Handheld Ultrasound Devices
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Stanford University
Phimosis, Foreskin; Tightness
Safety and Efficacy of the Sterile Single-use Circular Stapling Device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
Evaluation of the safety and efficacy of the sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China) in comparison with circumcision in adults patients with…
- Conditions
- Phimosis, Foreskin; Tightness, Redundant Prepuce
- Trial name
- CiCi-2021 (NCT04902898)
- Testing
- Circumcision in adults using sterile single-use circular stapling device, Circumcision in adults
- Where
- Greece
- Volunteers
- 100 people
- Sponsor
- University of Thessaly
Intrauterine Systems, Postpartum Immediate Contraception
Postpartum Immediate Contraception in Cesarean Deliveries-Comparison of Two Intrauterine Systems
To compare two intrauterine systems in order to avoid complications originating from short pregnancy interval and undesired pregnancies in the early postpartum period.
- Trial name
- NCT02941198
- Testing
- GyneFix, Cu T380 A
- Where
- Turkey (Türkiye)
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Healthy Volunteers
Validation of a Medical Device, a Mobile Spectrofluorimeter, Measuring Skin Autofluorescence in Healthy Volunteers.
The Institut has developed a spectrofluorimeter for the registration and monitoring of skin autofluorescence. This Spectrofluorometer must be initially validated in healthy volunteers.
- Trial name
- PHOTOFLUO (NCT02904616)
- Testing
- mobile spectrofluorimeter
- Where
- France
- Volunteers
- 32 people
- Sponsor
- Institut de Cancérologie de Lorraine
Cerebral Palsy (CP)
Evaluating the Bambini Teens Exoskeleton for Pediatric Cerebral Palsy
The goal of this clinical trial is to evaluate the safety and effectiveness of the Bambini Teens exoskeleton as a gait training tool in children aged 5 to 14 years diagnosed with cerebral palsy (CP).
- Trial name
- NCT07146932
- Testing
- Pediatric Lower Limb Exoskeleton (Bambini Teens)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- COSMO ROBOTICS CO., Ltd
Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis
Tornier Perform™ Reversed Monopost Study
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
- Conditions
- Non-inflammatory Degenerative Joint Disease, Rhematoid Arthritis, Correction of Functional Deformity, Fracture of the Humeral Head
- Trial name
- Monarch (NCT07764614)
- Testing
- Tornier Perform™ Reversed MonoPost
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Stryker Trauma and Extremities
Benign Gynecologic Neoplasm
Efficacy and Safety Evaluation of Vi-sealer
This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.
- Trial name
- NCT05629611
- Testing
- Vi-Sealer, Ligasure, Other AHD
- Where
- South Korea
- Volunteers
- 280 people
- Sponsor
- Hyun Park