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Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy

NCT00916643 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2024-04-02

Study results available
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Summary

The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular events or interventions, angina, and serious unanticipated adverse effects. Laboratory assessments will be made to document low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood components. Quality of life assessments will also be made.

The study will also assess the modifications to the H.E.L.P. System, including:

* use of a single heparin adsorber, instead of two smaller adsorbers;
* change in the supplier of the ultrafilter (from Secon to Toray);
* reduction in the number of blood lines from eleven to nine;
* change from a single-layer to a two-layer precipitate filter.

The safety and efficacy of the device specific to these modifications will be evaluated by comparing the safety and efficacy data from the patient registry to the data from the initial clinical study on the device as originally designed.

Conditions

  • Familial Hypercholesterolemia

Interventions

DEVICE

HELP Secura (apheresis treatment)

Process is described in Arm (above).

Sponsors & Collaborators

  • B. Braun Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-12-31
Primary Completion
2009-09-30
Completion
2009-09-30

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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 NCT00916643 on ClinicalTrials.gov