Trials / Withdrawn
WithdrawnNCT04076566
Malignant Ascites Alfapump® Study
Prospective Study in the Use of the Alfapump® in the Treatment of Malignant Ascites
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Sequana Medical N.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | alfapump system | active implantable device for treatment of malignant ascites |
Timeline
- Start date
- 2020-05-31
- Primary completion
- 2021-12-01
- Completion
- 2022-03-01
- First posted
- 2019-09-03
- Last updated
- 2020-08-10
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04076566. Inclusion in this directory is not an endorsement.