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Evaluation of the AMICUS RBCx System in Sickle Cell Patients

NCT02372877 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-07-29

Study results available
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Summary

The purpose of this study is to evaluate the performance of the AMICUS Red Blood Cell Exchange (RBCx) System (Exchange and Depletion/Exchange procedures) in patients with sickle cell disease.

Conditions

Interventions

DEVICE

Amicus Red Cell Exchange in SCD patients

Each patient will be treated with one RBCx procedure using the AMICUS RBCx System

Sponsors & Collaborators

  • Versiti

    collaborator OTHER

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • Barbara Ann Karmanos Cancer Institute

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • Phoenix Children's Hospital

    collaborator OTHER

  • Fenwal, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Swerdlow, MD · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-12-07
Completion
2018-01-19

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372877 on ClinicalTrials.gov