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NCT01764061 · ClinicalTrials.gov registry record

Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)

A clinical trial, sponsored by Haemonetics Corporation.

Completed
Registry status
60
Enrollment target

NCT01764061 is a clinical trial that has completed, run by Haemonetics Corporation. The registered enrollment target is 60 participants.

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The verdict

NCT01764061 has completed, sponsored by Haemonetics Corporation.

COMPLETED
Registry status
60 participants
Enrollment target

Study Summary

The purpose of this study is to validate that single units of RBCs collected by the Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood cells, and to provide data to support the 510(k) clearance of the MCS®+ 8150 system using LN832 disposable sets for this intended use.

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2013-01
Est. Completion 2013-09

Sponsor

Haemonetics Corporation

11 total trials

What the Registry Record Tells You About NCT01764061

The ClinicalTrials.gov registry entry for NCT01764061 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Haemonetics Corporation, which has 11 total studies on file at ClinicalTrials.gov.

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

NCT01764061 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01764061 about?

NCT01764061 is a clinical study titled "Clinical Investigational Protocol for 2 RBC Single Unit Recovery on MCS®+ 8150 Using LN832 Disposable Sets (US)". The purpose of this study is to validate that single units of RBCs collected by the Haemonetics MCS®+ 8150 system using LN832 disposable sets during an interrupted double red cell collection protocol meet all in vitro FDA requirements for non-leukoreduced red blood cells, and to provide data to supp...

What is the current status of trial NCT01764061?

This trial is currently completed. The enrollment target is 60 participants. The study started on 2013-01. Estimated completion is 2013-09.

Who is sponsoring clinical trial NCT01764061?

This trial is sponsored by Haemonetics Corporation, which has 11 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.