MedTrace Logo

Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

NCT01479218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-15

No results posted yet for this study

Summary

The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.

Conditions

  • Patent Ductus Arteriosus

Interventions

DEVICE

Occlutech PDA occluder

Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Principal Investigators

  • Ziyad M Hijazi, Professor · Rush University medical center, Chicago, USA

  • Alwi Mazeni, Dr · IJN Heart Institute, Kuala Lumpur, Malaysia

  • Viet Minh Tri Nguyen, Dr · Pediatric hospital no 2, Hochiminh city, Vietnam

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-02-28
Completion
2014-05-31

Countries

  • Malaysia
  • Vietnam

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479218 on ClinicalTrials.gov