Status:
WITHDRAWN
Malignant Ascites Alfapump® Study
Lead Sponsor:
Sequana Medical N.V.
Conditions:
Malignant Ascites
Eligibility:
All Genders
18+ years
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 patie...
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....
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age;
- 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.
- Subject has a life expectancy of ≥3 months as assessed by the treating physician, and is receiving or intended to receive anticancer therapy.
- 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
- Subject has evidence of multiple ascites loculation
- Ascites analysis with neutrophil count \>250/µl within 24-hours prior to implant.
- Subject has acute Urinary Tract Infection (UTI) within 24-hours of implantation assessed by urinalysis.
- Subject has skin infection of the abdominal wall at the area of implantation.
- Subject has a serum creatinine \> 1.5 mg/dL Subject has
- Subject has obstructive uropathy (bladder residual volume \>100 mL, determined by catheterization or abdominal ultrasound) in case of Lower Urinary Tract Symptoms (LUTS) .
- Existing bladder anomaly denying proper catheterization of the bladder.
- Subject has active bleeding or thrombocytopenia \< 45,000 X106/L.
- Subject on long-term prophylactic anticoagulation
- Subject is pregnant or a female of childbearing potential.
- Patient has recurrent requirement for MRI
- Subject is currently participating in an oncology trial which might be negatively affected by the alfapump as assessed by the treating physician
Key Trial Info
Start Date :
May 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04076566
Start Date
May 31 2020
End Date
March 1 2022
Last Update
August 10 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hammersmith Hospital
London, United Kingdom, W120HS