Trials / Completed
CompletedNCT06789224
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Lindis Bloodcare GmbH · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | CATUVAB | inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2023-11-25
- Completion
- 2024-04-14
- First posted
- 2025-01-23
- Last updated
- 2025-01-23
Locations
6 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06789224. Inclusion in this directory is not an endorsement.