Clinical trials: Longitudinal Studies
OSA
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of…
- Trial name
- SOUNDI (NCT06320795)
- Testing
- SOUNDI
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Biocubica srl
Coronary Arteriosclerosis
Scoreflex TRIO - Scoring PTCA Catheter
To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary…
- Trial name
- NCT05929313
- Testing
- OrbusNeich Scoreflex TRIO, OrbusNeich Scoreflex NC
- Where
- 4 sites in China
- Volunteers
- 210 people
- Sponsor
- OrbusNeich
Care Givers, Health
Positive Care Effect of the Digital Health Assistant ADELE for Patients with Care Level
Care is becoming an increasingly important topic in Germany due to the rising number of people in need of care. There are currently around 5 million people with a care level in Germany who are permanently dependent on help to…
- Conditions
- Care Givers, Health, Care of the Elderly, Health Care Delivery
- Trial name
- A0004 (NCT06741462)
- Testing
- Digital health assistant ADELE A0004
- Where
- 2 sites in Germany
- Volunteers
- 64 people
- Sponsor
- Alma Phil Gmbh
Chronic Pain
Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial
The aims of the study are to compare automatic control of spinal cord stimulation with manual control in patients with chronic pain of the trunk and limbs
- Trial name
- Panorama (NCT02161627)
- Testing
- Saluda Medical External Trial System
- Where
- 10 sites in United States
- Volunteers
- 69 people
- Sponsor
- Saluda Medical Pty Ltd
Dystrophic Epidermolysis Bullosa, DEB - Dystrophic Epidermolysis Bullosa
The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of wounds in patients with Dystrophic Epidermolysis Bullosa (DEB) for inclusion into the Krystal Biotech Phase III protocol of B-VEC…
- Trial name
- NCT04214002
- Where
- United States
- Sponsor
- Krystal Biotech, Inc.
Radiodermatitis
Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.
- Trial name
- NCT02534129
- Testing
- Difinsa53, Aquaphor
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- ProTechSure Scientific, Inc.
Patients Requiring Hip Replacement
MASTER SL Clinical Study
The purpose of this study is: to generate data to evaluate Orthopaedic Data Evaluation Panel (ODEP) rating to support existing short-term clinical results and CE documentation; to assess the clinical performance of the MASTER SL…
- Trial name
- NCT02126345
- Testing
- MASTER SL femoral stem and DELTA TT acetabular cup
- Where
- 4 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- Limacorporate S.p.a
Frozen Sections, Indocyanine Green (ICG)
A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS
The primary objective of this single-center study is to demonstrate the performance of cCeLL, used in real time, compared to frozen section analysis.
- Conditions
- Frozen Sections, Indocyanine Green (ICG), Brain Tumor
- Trial name
- NCT07254845
- Testing
- cCeLL In vivo, Indocyanine Green
- Volunteers
- 30 people
- Sponsor
- VPIX Medical
Cataract, Glaucoma
Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)
This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension…
- Conditions
- Cataract, Glaucoma, Ocular Hypertension
- Trial name
- NCT07218796
- Testing
- Bimatoprost Implant System, SpyGlass IOL, Timolol Maleate Ophthalmic Solution, 0.5%
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- SpyGlass Pharma, Inc.
Rare Diseases
NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants
Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One group will receive cWGS and a clinical report approximately 15 days after blood samples are received, while the other group will continue…
- Trial name
- NICU-Seq (NCT03290469)
- Testing
- clinical whole genome sequencing (cWGS)
- Where
- 5 sites in United States
- Volunteers
- 355 people
- Sponsor
- Illumina, Inc.
Hematuria - Cause Not Known
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria.
- Trial name
- CREDIBLE (NCT06394869)
- Testing
- Cxbladder Triage Plus
- Where
- 20 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Pacific Edge Limited
Blood Loss, Surgical
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.
- Trial name
- CLOT (NCT02359994)
- Testing
- PerClot Polysaccharide Hemostatic System, Arista AH
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Artivion Inc.
Lip Augmentation
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
- Trial name
- NCT05342753
- Testing
- Restylane Kysse
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Galderma R&D
Gamma-sarcoglycanopathy
Natural History Study in Patients With LGMDR5/2c
Prospective, longitudinal, interventional, multicenter natural history study to better understand the LGMDR5/2c disease physiopathology. The duration of participation for each patient will be up to 24 months.
- Trial name
- NCT06210672
- Where
- 3 sites in France, Tunisia
- Sponsor
- Atamyo Therapeutics
Healthy, Arrhythmia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT05640323
- Testing
- Norbert Device
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Enterostomy, Stoma Ileostomy
Safety and Performance of Flexima®/Softima® Stoma Appliances in Enterostomy Patients
The study is designed as a non-interventional, prospective, international, multi-center, post market follow-up investigation. The product under investigation will be used in routine clinical practice and according to Instructions…
- Conditions
- Enterostomy, Stoma Ileostomy, Stoma Colostomy
- Trial name
- NCT05373888
- Testing
- Flexima®/Softima® stoma bags
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- BBraun Medical SAS
Osteoarthritis of Hip
ArCom® and ArComXL® Polyethylene Data Collection
The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene.
- Trial name
- NCT00565786
- Testing
- ArCom® Polyethylene, ArComXL® Polyethylene
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- Zimmer Biomet
Pediatric ALL
Pediatric Cardiac Output Monitoring Observational Study
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution…
- Trial name
- POGO (NCT04465370)
- Testing
- Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
- Where
- 3 sites in United States
- Volunteers
- 89 people
- Sponsor
- Edwards Lifesciences
Ischemic Stroke
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe.
- Trial name
- PROMISE (NCT02678169)
- Testing
- Penumbra Aspiration System
- Where
- Germany
- Volunteers
- 204 people
- Sponsor
- Penumbra Inc.
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
Clinical Study of Coronary Extension Catheter
This prospective, multicenter, single-arm study plans to enroll 69 subjects. Subjects meeting the protocol criteria will receive treatment with coronary extension catheters.
- Trial name
- NCT07742345
- Testing
- Coronary Extension Catheter
- Where
- China
- Volunteers
- 69 people
- Sponsor
- BrosMed Medical Co., Ltd