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Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device

NCT06789224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-01-23

No results posted yet for this study

Summary

The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.

Conditions

  • Bladder Carcinoma
  • Prostate Tumor
  • Gallbladder Carcinoma
  • Endometrial Carcinoma
  • Gastric Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Colon Carcinoma
  • Non-small Cell Lung Cancer
  • Peritoneal Carcinomatosis
  • Kidney Carcinoma
  • Liver Carcinoma

Interventions

DEVICE

CATUVAB

inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates

Sponsors & Collaborators

  • Lindis Bloodcare GmbH

    lead INDUSTRY

Principal Investigators

  • Markus Heiss, MD · University Köln Merheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2023-11-25
Completion
2024-04-14

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT06789224 on ClinicalTrials.gov