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NCT01596595 · ClinicalTrials.gov registry record

Longitudinal Surveillance Study of the 4-SITE Lead/Header System

A clinical trial, sponsored by Boston Scientific Corporation.

Completed
Registry status
1,820
Enrollment target

NCT01596595 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 1,820 participants.

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The verdict

NCT01596595 has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
1,820 participants
Enrollment target

Study Summary

Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.

Trial Details

FieldValue
Enrollment Target 1,820 participants
Start Date 2013-04-04
Est. Completion 2020-02-18

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT01596595

The ClinicalTrials.gov registry entry for NCT01596595 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,820 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01596595 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01596595 about?

NCT01596595 is a clinical study titled "Longitudinal Surveillance Study of the 4-SITE Lead/Header System". Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integ...

What is the current status of trial NCT01596595?

This trial is currently completed. The enrollment target is 1,820 participants. The study started on 2013-04-04. Estimated completion is 2020-02-18.

Who is sponsoring clinical trial NCT01596595?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.