Status:
COMPLETED
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Lead Sponsor:
Fenwal, Inc.
Conditions:
Autoimmune Diseases
Renal Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
Detailed Description
Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to sele...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01210716
Start Date
September 1 2010
End Date
May 1 2011
Last Update
September 23 2013
Active Locations (4)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
University of Virginia
Charlottesville, Virginia, United States, 22903
4
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States, 53226