Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device

Completed · Phase 3

Conditions studied: Autoimmune Diseases, Renal Disorders, Hematologic Disorders, Oncologic Disorders

In brief

This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.

Key facts

Study ID

NCT01210716

Run by

Fenwal, Inc.

People needed

37

Starts

2010-09-01

Expected to finish

2011-05-01

Last updated by the study team

2013-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
• A physician's prescription for TPE for various non-emergent conditions.
• Test and Control TPE procedures that would be expected to be completed within approximately five weeks.

You may not qualify if…

• Patients under 18 years old.
• Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
• Patients with altered mental status that would prohibit the giving and understanding of informed consent.
• Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Virginia — Charlottesville, Virginia, United States
• BloodCenter of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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