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OSCAR I STUDY - The ONCObind CTC Removal Study

NCT06481397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-07-02

No results posted yet for this study

Summary

This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in metastatic PDAC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of PDAC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of PDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma with at least 5 U/mL CTCs in peripheral blood and/or portal vein.

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

DEVICE

ONCObind (Onco-Seraph) 100 Filter

The ONCObind (Onco-Seraph) 100 Microbind® Affinity Blood Filter (Onco-Seraph 100) manufactured by ExThera Medical Corporation in Martinez, CA. The Onco-Seraph 100 filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. Literature search yielded over 45 publications and 370 treated patients with Seraph platform technology for pathogen removals without significant safety concern. The achieved results from the above-mentioned testing and studies support the performance and safety of Onco-Seraph 100 consistent with the intended use. ExThera Medical concludes that the known and potential benefits of Onco-Seraph 100, when used to treat patients with PDAC, outweigh the known and potential risks when used according to the intended use.

Sponsors & Collaborators

  • ExThera Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Lakhmir Chawla, MD · ExThera Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-29
Primary Completion
2024-09-21
Completion
2024-10-18
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06481397 on ClinicalTrials.gov