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Completed Not applicable Interventional

NIT-OCCLUD PDA Phase II Sentinel Trial

ClinicalTrials.gov ID: NCT00828334

Public ClinicalTrials.gov record NCT00828334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Transcatheter Occlusion of Patent Ductus Arteriosus (PDA) With the NIT-OCCLUD PDA Occlusions System

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and efficacy outcomes with recommended OPCs.

Study identification

NCT ID
NCT00828334
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
PFM Medical, Inc
Industry
Enrollment
357 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
6 Months to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2002 (Type not available)
Primary completion
Jun 2007 (Actual)
Completion
Oct 2007 (Actual)
Last update posted
Mar 23, 2018

2002 – 2007

United States locations

U.S. sites
15
U.S. states
10
U.S. cities
15
Facility City State ZIP Site status
Mattel Children's Hospital at UCLA Los Angeles California 90095 —
Children's Hospital Central California Madera California 93638 —
Children's Hospital of Orange County Orange California 92868 —
A.I. Dupont Hospital for Children Wilmington Delaware 19899 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
Hope Children's Hospital Oak Lawn Illinois 60453 —
Children's Hospital of Illinois Peoria Illinois 61603 —
Riley Hospital for Children Indianapolis Indiana 46202-5225 —
Children's Hospital of Iowa Iowa City Iowa 52242 —
Children's Hospital of Akron Akron Ohio 44308 —
Columbus Children's Hospital Columbus Ohio 43205 —
St. Christopher's Hospital for Children Philadelphia Pennsylvania 19134 —
Driscoll Children's Hospital Corpus Christi Texas 78411 —
Children's Medical Center of Dallas Dallas Texas 75235 —
Children's Hospital and Regional Medical Center Seattle Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00828334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 23, 2018 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00828334 live on ClinicalTrials.gov.

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