Malignant Ascites Alfapump® Study

Sequana Medical N.V.

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Malignant Ascites

Interventions

alfapump systemDEVICE

active implantable device for treatment of malignant ascites

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is ≥ 18 years of age; 2. Subject has provided written informed consent; 3.Subject has recurrent malignant ascites defined as ≥2 therapeutic paracenteses in the month prior to enrolment; 4.Subject has sufficient baseline data documented for at least 4 paracentesis events in the last 3 months pre-implant, including date and volume; 5.Subject has ascites following neoplastic disease, as assessed by physician. In subjects with primary malignancy of the liver it should be confirmed that the ascites is due to malignancy and not due to underlying pre-existing cirrhosis. 6.Subject has a life expectancy of ≥3 months as assessed by the treating physician, and is receiving or intended to receive anticancer therapy. 7.Subject has the ability to comply with study procedures, including all follow-up visits at implanting centre when required, and ability to perform subject-required system tasks (charging). A subject with a caregiver who can comply with the study procedures and to perform the tasks required for appropriate pump function is allowed as well. Exclusion Criteria: 1. Subject has evidence of multiple ascites loculation 2. Ascites analysis with neutrophil count \>250/µl within 24-hours prior to implant. 3. Subject has acute Urinary Tract Infection (UTI) within 24-hours of implantation assessed by urinalysis. 4. Subject has skin infection of the abdominal wall at the area of implantation. 5. Subject has a serum creatinine \> 1.5 mg/dL Subject has 6. Subject has obstructive uropathy (bladder residual volume \>100 mL, determined by catheterization or abdominal ultrasound) in case of Lower Urinary Tract Symptoms (LUTS) . 7. Existing bladder anomaly denying proper catheterization of the bladder. 8. Subject has active bleeding or thrombocytopenia \< 45,000 X106/L. 9. Subject on long-term prophylactic anticoagulation 10. Subject is pregnant or a female of childbearing potential. 11. Patient has recurrent requirement for MRI 12. Subject is currently participating in an oncology trial which might be negatively affected by the alfapump as assessed by the treating physician

Locations (1)

Hammersmith Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Monthly therapeutic paracentesis frequency up to 3 months

Monthly therapeutic paracentesis frequency up to 3 months compared to the baseline therapeutic paracentesis frequency. The monthly therapeutic paracentesis frequency up to 3 months is defined as the average rate of therapeutic paracenteses during month 1, 2 and 3 post-implantation. Baseline therapeutic paracentesis frequency is defined as the average rate of therapeutic paracentesis in the 3 months prior to pump implantation.

Time frame: 3 months post-implantation

Secondary Outcomes

Monthly therapeutic paracentesis frequency up to 6 months

Monthly therapeutic paracentesis frequency up to 6 months compared to the baseline therapeutic paracentesis frequency. The monthly therapeutic paracentesis frequency at 6 months is defined as the average rate of therapeutic paracenteses during months 1 to 6 Baseline therapeutic paracentesis frequency is defined as the average rate of therapeutic paracentesis in the 3 months prior to pump implantation.

Time frame: 6 months post-implantation

Safety outcome: free survival

Therapeutic paracentesis free survival after Alfapump® implantation

Time frame: Time (days) to first paracentesis after implantation through 270 days post implantation

Efficacy outcome- Assessment of changes in Quality of Life

Changes in Quality of life after Alfapump® implantation, measured with validated EORTC cancer related Quality of life Questionnaire-CR29 (ColoRectal 29 questions) in subjects with colorectal malignancy.