Clinical trials: Medical Devices
Neuroendocrine Tumors
A Study to Collect the Somatuline® Injector Device Preferences of Patients Living With Neuroendocrine Tumor (NET) and Nurses Involved in the Care of Patients With NET
This study aims to investigate the treatment preferences of patients with Neuroendocrine Tumors (NETS) and nurses who are involved in the care of individuals with NETs.
- Trial name
- NCT05922579
- Where
- Australia
- Volunteers
- 191 people
- Sponsor
- Ipsen
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
NSCLC
Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors
The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.
- Trial name
- NCT06739031
- Testing
- PEF Treatment
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Energenx Medical LTD.
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
Uterine Hemorrhage
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena.
- Trial name
- NCT01295294
- Testing
- Tranexamic acid, Mefenamic acid, Mirena (Levonorgestrel IUS, BAY86-5028)
- Where
- 12 sites in Denmark, Ireland and 1 more
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Bayer
Low Back Pain
Evaluation of the Japet.W+ Medical Device for Low Back Pain Management
The JAPET.W+ medical device is a new dynamic distraction support system. It could be considered as a new solution in the therapeutic arsenal for managing common low back pain.
- Trial name
- EXODOMICILE (NCT07195422)
- Testing
- Japet.W+, Control (Standard treatment)
- Where
- 2 sites in France
- Volunteers
- 102 people
- Sponsor
- Japet Medical Devices
Mid-face Volume Deficit
Efficacy and Safety of Rejuviel V in the Correction of Midface Volume Deficit
The purpose is to evaluate the efficacy and confirm the safety of Rejeunesse Contour® with Lidocaine compared to Juvederm® Voluma® with Lidocaine for the temporary improvement of mid-face volume (including the cheekbone area, the…
- Trial name
- NCT07162610
- Testing
- Rejuviel V® with lidocaine, JUVEDERM® VOLUMA® with lidocaine
- Where
- South Korea
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- PharmaResearch Co.,Ltd
Hallux Valgus
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
- Trial name
- PECA (NCT05361317)
- Testing
- Nexis® PECA Bunion device
- Where
- 4 sites in France
- Volunteers
- 86 people
- Sponsor
- Novastep
Spinal Disorders/Injuries
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries…
- Trial name
- RWE Spine (NCT05082090)
- Testing
- Spinal Surgery
- Where
- 20 sites in United States, Germany and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Orthofix Inc.
Acute Upper Gastrointestinal Hemorrhage, Acute Upper Gastrointestinal Bleeding
Clinical Investigation of Safety and Performance of a Medical Device (ClearPlasma) for the Treatment of Patients With Acute Upper Gastrointestinal Hemorrhage.
Pre-market, multi-center, international, double-blind, randomized, controlled, prospective, first-in-human clinical investigation of a Class IIb Investigational Medical Device, in which Patients presenting with acute upper…
- Trial name
- NCT04174989
- Testing
- Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device), Regular fresh-frozen plasma (not treated)
- Where
- 8 sites in Czechia, Israel and 1 more
- Volunteers
- 53 people
- Sponsor
- PlasFree Ltd.
Skin Reaction to Mechanical, Thermal and Radiation Stimuli, Skin Sensitisation
Study Comparing iNPWT Dressing and Devices Affect on Bioburden Levels and Skin Condition After Seven Days
Incisional dressings aim to prevent contamination of an incisional wound and protect against skin irritation. Surgeons use incisional negative pressure wound therapy (iNPWT) to manage incisional wounds.
- Trial name
- HHiNPWT7DC (NCT05559697)
- Testing
- Sponsor incisional negative pressure wound therapy device and dressing, Standard of Care incisional negative pressure wound therapy system
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- DeRoyal Industries, Inc.
Intrauterine Devices, Medicated
A Cross-sectional, Observational Multicenter Study to Assess the Reasons for Choosing the 3-year Hormonal IUD and Level of IUDs Knowledge Among Women Aged 18 to 29 Years
A cross-sectional, observational multicenter study to assess the reasons for choosing the 3-year hormonal IUD and level of IUDs knowledge among women aged 18 to 29 years.
- Trial name
- ANALIA (NCT02903888)
- Testing
- Levonorgestrel (Jaydess, Skyla, BAY86-5028)
- Where
- Spain
- Volunteers
- 886 people
- Sponsor
- Bayer
Atrophic Vaginitis, Atrophic Vulvovaginitis
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
This clinical study will evaluate the efficacy and safety of F-GYN, a sterile injectable medical device containing non-crosslinked hyaluronic acid, in adult women with moderate to severe vaginal dryness and symptoms related to…
- Conditions
- Atrophic Vaginitis, Atrophic Vulvovaginitis, Vaginal Atrophy, Dyspareunia
- Trial name
- F-GYN (NCT07701863)
- Testing
- F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel, Standard Non-Hormonal Symptomatic Care
- Where
- 3 sites in Poland
- Volunteers
- 130 people
- Sponsor
- Biovico Sp. z o.o.
Migraine, Episodic Migraine
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)
Randomized study of two digital therapeutics for the prevention of episodic migraine in patients currently receiving Calcitonin Gene-Related Peptide (CGRP) Inhibitor Therapy
- Conditions
- Migraine, Episodic Migraine, Headache, Headache, Migraine
- Trial name
- NCT06004388
- Testing
- Click Digital Therapeutic
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Click Therapeutics, Inc.
Chronic Obstructive Pulmonary Disease
Relative Bioavailability Study With Abediterol Administered Via Three Different Inhalation Devices in Healthy Volunteers.
The study is intended to assess the relative bioavailability of 2 different abediterol nebulised formulations (test) and the dry powder formulation (reference).
- Trial name
- NCT04199598
- Testing
- Abediterol (2.4 μg), Abediterol (4.8 μg), Abediterol (2.5 μg)
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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.
Catheters, Indwelling
Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices
This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood).
- Trial name
- NCT00073515
- Testing
- Alfimeprase
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- ARCA Biopharma, 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
Breast Cancer, Breast Tumor Benign
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment
Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2) 1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS) 2.
- Trial name
- EMBLEDDA-MMG (NCT06428799)
- Testing
- Carebot AI MMG
- Where
- 3 sites in Czechia
- Volunteers
- 122 people
- Sponsor
- Carebot s.r.o.