Safety & Effectiveness Study of the Solysafe Septal Occluder

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02220270` - Hyperion™ International Registry Trial	N/A
Suspended	`NCT01536717` - Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery	Phase 4
Completed	`NCT02552485` - Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions	N/A
Completed	`NCT02529111` - Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT02220270 - Hyperion™ International Registry Trial

N/A

Suspended

NCT01536717 - Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery

Phase 4

Completed

NCT02552485 - Evaluation of Latent Pulmonary Arterial Hypertension in Congenital Shunt Lesions

N/A

Completed

NCT02529111 - Percutaneous Closure of Atrial Septal Defects in Children: Integration of 3D Echocardiography and Fluoroscopy Imaging.

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT00353509
Study type	Interventional
Source	Carag AG
Contact
Status	Completed
Phase	N/A

Safety and Effectiveness Study of the Solysafe Septal Occluder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms