Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood

Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03058809

Enrollment

100

Registered

2017-02-23

Start date

2018-09-30

Completion date

2019-05-31

Last updated

2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer

Brief summary

This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.

Interventions

DEVICEOncopheresis

Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Subjects will be their own controls

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Confirmed diagnosis of breast, colon or prostate cancer * No prior cancer therapy or failed first line therapy * \>= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment * \> 1 month life expectancy * Adequate baseline hematological function as assessed by the following laboratory values: * Hemoglobin \> 9 g/dl * Platelets \> 100,000/mm3 * WBC \> 3,000/mm3 * Absolute Neutrophil Count \> 1,500/mm3

Exclusion criteria

* Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism * Patients with known immunodeficiency virus (HIV)

Design outcomes

Primary

Measure	Time frame	Description
Change in Circulating Tumor Cells	% change will be determined on the day of treatment	% change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System

Secondary

Measure	Time frame	Description
Immune system activation	Immune system activation biomarkers will be followed for 7 days post treatment	To assess the effect of oncopheresis on immune system activation

Contacts

Primary ContactMichael A Patz

michael.patz@viatarctcsolutions.com9787128210

Backup ContactSteve Keaney

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026