Clinical trials: Defects
22Q11.2 Deletion Syndrome
Open-Label Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome (INSPIRE)
To evaluate the safety and tolerability of ZYN002 administered as a transdermal gel formulation, for up to 38 weeks, in participants ages 4 to <18 years, in the treatment of 22q.11.2 Deletion syndrome (22qDS).
- Trial name
- INSPIRE (NCT05149898)
- Testing
- ZYN002
- Where
- 3 sites in United States, Australia
- Volunteers
- 20 people
- Sponsor
- Harmony Biosciences Management, Inc.
Tumor, Cerebral Ventricle, Tumor, Cerebellar
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
- Conditions
- Tumor, Cerebral Ventricle, Tumor, Cerebellar, Aneurysm Cerebral, Trauma, Brain
- Trial name
- LYOPLACE (NCT05441618)
- Testing
- Lyoplant®
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Aesculap AG
Down Syndrome, Edwards Syndrome
Whole Blood Specimen Collection From Pregnant Subjects
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02430584
- Testing
- Observational - no intervention
- Where
- United States
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- Progenity, Inc.
Patent Foramen Ovale
CeraFlex PFO Closure System PMCF Study
The purpose of this study is to compile real-world data on patient outcomes and evaluate the procedural success and performance of the CeraFlex™ PFO Closure System.
- Trial name
- NCT06120270
- Testing
- CeraFlex PFO Closure System
- Where
- 15 sites in Germany, South Korea
- Volunteers
- 180 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Soft Tissue, Soft Tissue Defects
First-in-Human Safety Study for Fractomer™ Biomatrix
The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ Biomatrix) in healthy volunteers.
- Conditions
- Soft Tissue, Soft Tissue Defects, Subcutaneous Injection
- Trial name
- NCT07151638
- Testing
- Implantation (injection) of a new biomatrix for soft tissue support.
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- inSoma Bio, Inc.
X-Linked Retinitis Pigmentosa
Gene Therapy for X-linked Retinitis Pigmentosa (XLRP) - Retinitis Pigmentosa GTPase Regulator (RPGR)
Phase 1 of the study is a dose escalation of the subretinal administration of AAV5-hRKp.RPGR vector to assess the safety of this vector in participants with XLRP caused by mutations in RPGR.
- Trial name
- NCT03252847
- Testing
- AAV5-RPGR
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 49 people
- Sponsor
- MeiraGTx UK II Ltd
Congenital Heart Disease
A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease
The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.
- Trial name
- NCT00538785
- Testing
- Motavizumab, Palivizumab
- Where
- 152 sites in United States, Austria and 15 more
- Volunteers
- 1,236 people
- Sponsor
- MedImmune LLC
Tetrology of Fallot, Pulmonary Stenosis
MASA Valve Early Feasibility Study
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and…
- Conditions
- Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels
- Trial name
- MVEFS (NCT05452720)
- Testing
- Surgical Right Ventricular Outflow Tract Reconstruction
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- PECA Labs
Fertility Issues, Single-Gene Defects
Whole Genome Sequencing (WGS) on IVF Embryos and Individual Patients
This research project aims to utilise recent advances in whole genome sequencing of preimplantation genetic diagnosis embryos to investigate the impact of paternal age on de novo mutation rates in IVF embryos.
- Trial name
- EmbryoWGS (NCT05739890)
- Testing
- Embryo genome sequencing, Parents genome sequencing
- Where
- 4 sites in United States, Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- GenEmbryomics Pty. Ltd
Hernia
Large Abdominal Hernia Repair With SurgiMend 3.0
The rate of hernia recurrence at one year following repair of a large abdominal hernia with a biologic mesh is high, ranging from 30% to 100%, with a reported historic average rate of 40%.
- Trial name
- BRIDGE (NCT00892333)
- Where
- 8 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Wound of Skin, Ulcers
TrueLok Elevate PMCF Study
The TrueLok Elevate Transverse Bone Transport System is a modular external fixation device designed for transverse bone transport.
- Conditions
- Wound of Skin, Ulcers, Soft Tissue Defect
- Trial name
- NCT07079774
- Testing
- Transverse Bone Transport System
- Where
- 14 sites in Germany, Italy and 4 more
- Volunteers
- 153 people
- Sponsor
- Orthofix s.r.l.
Cartilage Defects of the Knee
NOVOCART® Inject Plus for Cartilage Defects of the Knee
Prospective, Multicenter, Single-arm Phase III Clinical Trial to Evaluate the Efficacy and Safety of NOVOCART® Inject plus in the Treatment of Cartilage Defects of the Knee.
- Trial name
- NCT03319797
- Testing
- NOVOCART® Inject plus
- Where
- 20 sites in Czechia, Germany and 3 more
- Volunteers
- 100 people
- Sponsor
- Tetec AG
Fluorosis, Oral Deseases
12 Month Follow up in Vivo Icon Study on Fluorotic Teeth
Clinical trial to investigate the clinical efficiency of resin infiltration compared to microabrasion in the improvement of dental fluorosis.
- Trial name
- NCT02925780
- Testing
- Resin infiltration, Microabrasion
- Sponsor
- DMG Dental Material Gesellschaft mbH
Pathological Processes in the Posterior Fossa, Dura Defects
Fibrin Sealant for the Sealing of Dura Sutures
The purpose of this study is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura…
- Trial name
- NCT00681824
- Testing
- Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Standard of care
- Where
- 13 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Baxter Healthcare Corporation
Prostate Cancer
A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer
The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC)…
- Trial name
- NCT03148795
- Testing
- Talazoparib
- Where
- 120 sites in United States, Australia and 12 more
- Volunteers
- 128 people
- Sponsor
- Pfizer
Primary Ciliary Dyskinesia (PCD)
Study of Inhaled RCT1100 in Adults With PCD Caused by Pathogenic Mutations in the DNAI1 Gene to Measure Mucociliary Clearance
This is a multi-dose study with RCT1100 and is designed to provide safety, tolerability and preliminary efficacy data for future clinical studies.
- Trial name
- NCT06633757
- Testing
- RCT1100
- Where
- 3 sites in United States, Denmark and 1 more
- Volunteers
- 14 people
- Sponsor
- ReCode Therapeutics
Long QT Syndrome Type 3
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3.
- Trial name
- NCT02300558
- Testing
- Eleclazine
- Where
- 12 sites in United States, Canada and 6 more
- Volunteers
- 41 people
- Sponsor
- Gilead Sciences
Atrial Septal Defect Secundum
ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
- Trial name
- ASO 522 (NCT02353351)
- Testing
- atrial septal occluder
- Where
- 65 sites in United States
- Volunteers
- 602 people
- Sponsor
- Abbott Medical Devices
Pulmonary Artery Stenosis, Aortic Coarctation
Minima Stent System Post- Approval Study (PAS)
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States.
- Trial name
- NCT06828770
- Testing
- Minima Stent System
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Renata Medical
Heart Septal Defects, Atrial, Atrial Septal Defect
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.
- Trial name
- NCT03601039
- Testing
- Absnow Absorbable ASD Closure System
- Where
- 14 sites in China
- Volunteers
- 165 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.