Clinical trial NCT04076566: Malignant Ascites Alfapump® Study
Official title: Prospective Study in the Use of the Alfapump® in the Treatment of Malignant Ascites
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Malignant Ascites
Keywords: OVARIAN
COLORECTAL
PARACENTESIS
Lead sponsor: Sequana Medical N.V.
Sponsor class: INDUSTRY
First posted: 2019-09-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will be asked to enrol subjects meeting the inclusion and exclusion criteria .This study population is highly palliating with overall limited prognosis and significant comorbidities and possibly reduced performance status. Subjects must be under the care of an oncologist specialised in their disease. In the case of hepatic involvement, a hepatologist, and in the case of ovarian or breast cancer a gynaecologic oncologist accustomed to managing subjects with advanced malignancy. Subjects will be enrolled into the trial from the clinical practices of the investigators. Suitable subjects will undergo screening, including detailed medical history, paracentesis history and blood tests, to ensure compliance with study inclusion / exclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Monthly therapeutic paracentesis frequency up to 3 months
timeFrame: 3 months post-implantation
Secondary outcomes:
measure: Monthly therapeutic paracentesis frequency up to 6 months
timeFrame: 6 months post-implantation
measure: Safety outcome: free survival
timeFrame: Time (days) to first paracentesis after implantation through 270 days post implantation
measure: Efficacy outcome- Assessment of changes in Quality of Life
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Efficacy outcome- Assessment of changes in Quality of Life
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Efficacy outcome- Assessment of changes in Quality of Life
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Nutritional status outcome
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Nutritional status outcome
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Nutritional status outcome
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Nutritional status outcome
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Nutritional status outcome
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Nutritional status outcome
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline
measure: Pump performance
timeFrame: at 1-month, 3-month, 6-month and 9-month follow-up
measure: Pump performance outcome - pump survival
timeFrame: Time (days) from implantation until explantation due to technical causes through study completion up to 270 days post-pump implantation
measure: Pump performance outcome - pump survival
timeFrame: Time (days) from implantation until first exchange due to technical causes through study completion up to 270 days post-pump implantation
measure: Pump performance outcome
timeFrame: through study completion up to 270 days post-pump implantation
measure: Pump performance outcome
timeFrame: throug study completion up to to 270 days post-pump implantation
measure: Safety outcome - subject survival
timeFrame: Time (days) until exitus through study completion up to 270 days post-pump implantation
measure: Safety outcome- Bladder metastasis: Freedom from metastatic bladder wall infiltration
timeFrame: at 6-month follow-up
measure: Safety outcome- Worsening of renal function
timeFrame: at 3-month, 6-month and 9-month follow-up compared to baseline
measure: Safety outcome- Incidence of device related infection
timeFrame: at 3-month, 6-month and 9-month follow-up
measure: Safety outcome- Incidence of Procedure related events
timeFrame: At 1 month follow-up.
measure: Safety outcome- Incidence of Device related events
timeFrame: at 3-month, 6-month and 9-month follow-up
measure: Device failure
timeFrame: Through study completion up to 270 days post-pump implantation
Other outcomes:
measure: Exploratory outcome- liquid biopsies
timeFrame: 2-days, 7-days, 3-months, 6-months and 9-months post implant
measure: Exploratory outcome - anticancer treatment
timeFrame: Time (days) to event through study completion up to 270 days post-pump implantation
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial Hospital, London, UK
name: Christina Fotopoulou, Prof, MD
role: PRINCIPAL_INVESTIGATOR
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