Malignant Ascites Clinical Trial
Official title:
Prospective Study in the Use of the Alfapump® in the Treatment of Malignant Ascites
ProMAS is a prospective post-marketing, single-arm study to assess performance and safety of the Alfapump® system in the treatment of patients with malignant ascites. The study aims to enroll 40 patients in up to 8 sites in Europe.
The Prospective Malignant Ascites Alfapump® study is a single-arm, prospective study to evaluate the performance and safety of the Alfapump® system in the treatment of patients with malignant ascites. The Alfapump® system is a fully implantable programmable pump, able to move ascitic fluid from the peritoneal cavity to the bladder via 2 catheters. The Alfapump® has obtained CE (Conformité Européenne) mark approval for the indication of malignant ascites. The primary objective of the study is to assess the performance of the system to remove ascites. Secondary objectives are to evaluate the safety and tolerability of the Alfapump® in the treatment of malignant ascites for a total follow-up period of 9 months, and to evaluate quality of life (QoL) by reduction or elimination of paracentesis requirement. Furthermore the study includes an exploratory scientific objective as to feasibility to obtain 'liquid biopsy' samples suitable for analysis in a non-invasive way after Alfapump® implantation. 40 patients with malignant ascites will be enrolled in up to 8 sites in Europe (Belgium, United Kingdom, Switzerland). Specific sub-analysis of data from patients with gynecological (ovarian) cancer is planned. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06200376 -
A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer
|
Phase 1 | |
| Completed |
NCT04051112 -
Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites
|
Phase 1 | |
| Completed |
NCT00836654 -
Study in EpCAM Positive Patients With Symptomatic Malignant Ascites Using Removab Versus an Untreated Control Group
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05501340 -
PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03550560 -
EUS-Guided Drainage of Refractory Malignant Ascites
|
||
| Recruiting |
NCT04501744 -
A Study of M701 (EpCAM and CD3) in Malignant Ascites
|
Phase 1 | |
| Terminated |
NCT00028782 -
EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
|
N/A | |
| Recruiting |
NCT05477927 -
Dual-targeting VEGFR1 and PD-L1 CAR-T for Cancers Patients With Pleural or Peritoneal Metastases
|
Phase 1 | |
| Active, not recruiting |
NCT06266091 -
Treat Malignant Ascites Caused by Gastrointestinal or Ovarian Cancer With M701 Bispecific Antibody
|
Phase 2 | |
| Enrolling by invitation |
NCT01854866 -
Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion
|
Phase 2 | |
| Recruiting |
NCT03230708 -
Clinical Study of Autologous Erythrocytes Derived MPs Packaging MTX Peritoneal Perfusion to Treat Malignant Ascites
|
Phase 1/Phase 2 | |
| Completed |
NCT01327235 -
Endostar and/or Cisplatin for Treatment of Malignant Pleural Effusion or Ascites
|
Phase 2 | |
| Not yet recruiting |
NCT04985357 -
Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs
|
||
| Terminated |
NCT02496286 -
Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
|
Phase 1 | |
| Completed |
NCT01532427 -
ALFApump System Post Marketing Surveillance Registry
|
||
| Completed |
NCT00326885 -
Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
|
Phase 2 | |
| Recruiting |
NCT02530398 -
A Tolerance Trial of Cinobufacini Injection Intraperitoneal Perfusion on Digestive System Cancer With Ascites
|
Phase 1 | |
| Withdrawn |
NCT00908219 -
A Study of Bevacizumab to Prevent Malignant Ascites
|
Phase 2 | |
| Recruiting |
NCT06016179 -
Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT03736122 -
A Study of Syngenon (BSG-001) for Inhalation in Subjects With Malignant Pleural Effusion and/or Malignant Ascites
|
Phase 1/Phase 2 |