Clinical trials: Defects
Turner Syndrome
The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
This is a multicenter, randomized, open-label, positive-controlled phase III confirmatory clinical study. A total of 84 children with short stature due to Turner Syndrome (TS) are planned to be enrolled.
- Trial name
- NCT07614152
- Testing
- Inpegsomatropin-Injection, Givopegsomatropin Solution Injection
- Where
- 51 sites in China
- Volunteers
- 84 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Stroke, Patent Foramen Ovale
AMPLATZER PFO Occluder Post Approval Study
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
- Trial name
- PFO PAS (NCT03309332)
- Testing
- AMPLATZER™ PFO Occluder
- Where
- 88 sites in United States, Canada and 5 more
- Volunteers
- 1,214 people
- Sponsor
- Abbott Medical Devices
Septal Defect, Atrial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT00581308
- Testing
- GORE® HELEX® Septal Occluder
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Atrial Septal Defect, Ventricular Septal Defect
Intravenous L-Citrulline to Treat Children Undergoing Heart Bypass Surgery : Revised Protocol
This clinical trial will determine the safety and effectiveness of intravenous L-citrulline in children undergoing cardiopulmonary bypass during heart surgery.
- Conditions
- Atrial Septal Defect, Ventricular Septal Defect, Atrioventricular Septal Defect
- Trial name
- NCT01120964
- Testing
- Intravenous L-Citrulline
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Cardiomyopathies, Heart Diseases
PKP2-ACM Natural History Study
The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.
- Conditions
- Cardiomyopathies, Heart Diseases, Cardiovascular Diseases, Genetic Diseases
- Trial name
- NCT06644742
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 36 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Grafting, Bone
Osteoconduction Potential of an Injectable Calcium Phosphate in Orthopaedic Surgery in Fillings of Osseous Defects
The purpose of this non-comparative study is to test, for the first time, the bioactivity of a new "ready to use" calcium phosphate biomaterial in fillings of little losses of osseous substance from various origins, such as…
- Trial name
- NCT00206791
- Testing
- MBCP-Gel (tm), MBCP Gel
- Where
- 4 sites in France
- Volunteers
- 3 people
- Sponsor
- Biomatlante
Advanced Solid Tumor
A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours
Based on overall response rate (ORR) as assessed by the Independent Review Committee (IRC) against the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria for Solid Tumor Efficacy, To evaluate the efficacy of…
- Trial name
- NCT06873854
- Testing
- LM-108, Toripalimab
- Where
- China
- Volunteers
- 84 people
- Sponsor
- LaNova Medicines Limited
Failure of Fontan Type Circulation, Fenestration
Occlutech AFR Fontan Study
The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation.
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Trial name
- NCT07532369
- Testing
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Occlutech International AB
Abdominal Wall Defect, Ventral Hernia
Clinical Study on the Safety of SAFIL® MESH
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
- Conditions
- Abdominal Wall Defect, Ventral Hernia, Abdominal Hernia, Fascial Hernia
- Trial name
- SAFIL_MESH (NCT04947202)
- Testing
- Hernioplasty
- Where
- 2 sites in Spain
- Volunteers
- 152 people
- Sponsor
- Aesculap AG
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where…
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NordiPAD (NCT01604161)
- Testing
- somatropin
- Where
- Japan
- Volunteers
- 2,016 people
- Sponsor
- Novo Nordisk A/S
Structural Heart Diseases, Atrial Septal Defect
Cardiac Interventional ICE Imaging Trial
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac
- Trial name
- INTELICE (NCT06344494)
- Testing
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- ICE Intelligent Healthcare Co., Ltd
E04.525.190, Craniotomy
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Trial name
- NCT01282645
- Testing
- PSI in PEEK
- Where
- 30 sites in Austria, Belgium and 13 more
- Sponsor
- Synthes GmbH
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Safety and Efficacy of Long-term Somatropin Treatment in Children
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age
- Trial name
- GrowthWIN II (NCT01543867)
- Testing
- somatropin
- Where
- Germany
- Volunteers
- 5,442 people
- Sponsor
- Novo Nordisk A/S
Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter Study
The purpose of this study is to evaluate the safety and effectiveness of the TPV in patients with pulmonary valve dysfunction.
- Conditions
- Congenital Heart Defect, Pulmonary Valve; Insufficiency, Congenital, Pulmonary Valve Stenosis
- Trial name
- NCT03110861
- Testing
- Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement
- Where
- 5 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Taewoong Medical Co., Ltd.
Cartilage Disease
Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with…
- Trial name
- NINJA (NCT05391841)
- Testing
- NOVOCART Inject
- Where
- 6 sites in Germany
- Sponsor
- Tetec AG
Non-small Cell Lung Cancer, Head and Neck Cancer
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors
This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors
- Trial name
- NCT03518554
- Testing
- JAB-3068
- Where
- 4 sites in United States
- Volunteers
- 38 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
Bone Defects
Calcium Phosphate Cement As Bone Void Filler
This is an observational, prospective, non-randomised, post market clinical follow-up study to compile clinical data on performance and safety of the synthetic bone graft substitute and to assess that the performance and safety…
- Trial name
- NCT04645186
- Testing
- bone graft substitute
- Where
- Portugal
- Volunteers
- 40 people
- Sponsor
- Bioceramed
Patent Foramen Ovale, Cryptogenic Stroke
Safety and Efficacy of Cera™ Patent Foramen Ovale Occluders.
To evaluate the performance of Cera™ patent foramen ovale occluders developed by Lifetech Scientific (Shenzhen) Co., LTD;
- Trial name
- NCT05774288
- Testing
- Cera™ patent foramen ovale occluders, Another patent foramen ovale occluders
- Where
- 14 sites in China
- Volunteers
- 244 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Angelman Syndrome
CHAMPION: A Study to Evaluate the Efficacy and Safety of Obudanersen (ION582) in Children and Adults With Angelman Syndrome (AS)
The primary purpose of the study is to evaluate efficacy of obudanersen in participants with AS due to uniparental disomy or imprinting defects (UPD/ID) as measured through expressive communication.
- Trial name
- NCT07782827
- Testing
- obudanersen
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Ionis Pharmaceuticals, Inc.