Malignant Ascites
Conditions
Keywords
OVARIAN, COLORECTAL, PARACENTESIS
Brief summary
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.
Detailed description
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.
Interventions
DEVICEalfapump system
active implantable device for treatment of malignant ascites
Sponsors
Sequana Medical N.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly therapeutic paracentesis frequency up to 3 months | 3 months post-implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monthly therapeutic paracentesis frequency up to 6 months | 6 months post-implantation | 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. |
| Safety outcome: free survival | Time (days) to first paracentesis after implantation through 270 days post implantation | Therapeutic paracentesis free survival after Alfapump® implantation |
| Efficacy outcome- Assessment of changes in Quality of Life | at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline | 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. |
| Nutritional status outcome | at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline | Change in nutritional status assessed by Psoas muscle measurement |
| Pump performance | at 1-month, 3-month, 6-month and 9-month follow-up | Total Monthly volume of ascitic fluid removed (sum of volumes removed during each month via either Alfapump® and via therapeutic paracentesis) |
| Pump performance outcome - pump survival | Time (days) from implantation until explantation due to technical causes through study completion up to 270 days post-pump implantation | Pump survival through study completion, up to 270 days post-pump implantation |
| Pump performance outcome | through study completion up to 270 days post-pump implantation | Frequency of hospitalisations following Alfapump® implantation through study completion up to 270 days post-pump implantation |
| Safety outcome- Incidence of Device related events | at 3-month, 6-month and 9-month follow-up | Incidence of any Device-related adverse events |
| Device failure | Through study completion up to 270 days post-pump implantation | Incidence of device failure resulting in re-intervention (Revision, exchange or explantation) through study completion up to 270 days post-pump implantation |
| Safety outcome - subject survival | Time (days) until exitus through study completion up to 270 days post-pump implantation | Subject overall survival after Alfapump® implantation through study completion up to 270 days post-pump implantation |
| Safety outcome- Bladder metastasis: Freedom from metastatic bladder wall infiltration | at 6-month follow-up | Freedom from metastatic bladder wall infiltration as assessed by cystoscopy |
| Safety outcome- Worsening of renal function | at 3-month, 6-month and 9-month follow-up compared to baseline | Incidence of subjects suffering Renal function deterioration, defined as a rise in serum creatinine of ≥50% or ≥0.3mg/dl . |
| Safety outcome- Incidence of device related infection | at 3-month, 6-month and 9-month follow-up | Incidence of Device-related infections following pump-implantation |
| Safety outcome- Incidence of Procedure related events | At 1 month follow-up. | Incidence of Procedure related adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcome- liquid biopsies | 2-days, 7-days, 3-months, 6-months and 9-months post implant | Incidence of successful acquisition of ascitic fluid samples appropriate for oncological analysis via Alfapump® function |
| Exploratory outcome - anticancer treatment | Time (days) to event through study completion up to 270 days post-pump implantation | Incidence of Initiation of new / change to existing anticancer treatment through study completion up to 270 days post-pump implantation |
Countries
United Kingdom
Outcome results
None listed