Malignant Ascites Alfapump® Study

NCT ID: NCT04076566

Last Updated: 2020-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2022-03-31

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.

Conditions

Malignant Ascites

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

alfapump system

active implantable device for treatment of malignant ascites

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sequana Medical N.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Fotopoulou, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Imperial Hospital, London, UK

Locations

Hammersmith Hospital

London, , United Kingdom

Countries

United Kingdom

References

European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.

Reference Type: BACKGROUND

PMID: 20633946 (View on PubMed)

Pache I, Bilodeau M. Severe haemorrhage following abdominal paracentesis for ascites in patients with liver disease. Aliment Pharmacol Ther. 2005 Mar 1;21(5):525-9. doi: 10.1111/j.1365-2036.2005.02387.x.

Reference Type: BACKGROUND

PMID: 15740535 (View on PubMed)

Lin CH, Shih FY, Ma MH, Chiang WC, Yang CW, Ko PC. Should bleeding tendency deter abdominal paracentesis? Dig Liver Dis. 2005 Dec;37(12):946-51. doi: 10.1016/j.dld.2005.07.009. Epub 2005 Sep 26.

Reference Type: BACKGROUND

PMID: 16185942 (View on PubMed)

Gines P, Tito L, Arroyo V, Planas R, Panes J, Viver J, Torres M, Humbert P, Rimola A, Llach J, et al. Randomized comparative study of therapeutic paracentesis with and without intravenous albumin in cirrhosis. Gastroenterology. 1988 Jun;94(6):1493-502. doi: 10.1016/0016-5085(88)90691-9.

Reference Type: BACKGROUND

PMID: 3360270 (View on PubMed)

Sola R, Vila MC, Andreu M, Oliver MI, Coll S, Gana J, Ledesma S, Gines P, Jimenez W, Arroyo V. Total paracentesis with dextran 40 vs diuretics in the treatment of ascites in cirrhosis: a randomized controlled study. J Hepatol. 1994 Feb;20(2):282-8. doi: 10.1016/s0168-8278(05)80070-4.

Reference Type: BACKGROUND

PMID: 7516361 (View on PubMed)

Gines A, Fernandez-Esparrach G, Monescillo A, Vila C, Domenech E, Abecasis R, Angeli P, Ruiz-Del-Arbol L, Planas R, Sola R, Gines P, Terg R, Inglada L, Vaque P, Salerno F, Vargas V, Clemente G, Quer JC, Jimenez W, Arroyo V, Rodes J. Randomized trial comparing albumin, dextran 70, and polygeline in cirrhotic patients with ascites treated by paracentesis. Gastroenterology. 1996 Oct;111(4):1002-10. doi: 10.1016/s0016-5085(96)70068-9.

Reference Type: BACKGROUND

PMID: 8831595 (View on PubMed)

MEDDEV 2.12-1, rev 7, Guidelines on a medical device vigilance system.

Reference Type: BACKGROUND

Bureau C, Adebayo D, de Rieu MC, Elkrief L, Valla D, Peck-Radosavljevic M, McCune A, Abbadi R, Vargas V, Simon-Talero M, Cordoba J, Angeli P, Rosi S, MacDonald S, Malago M, Stepanova M, Younossi ZM, Trepte C, Watson R, Borisenko O, Sun S, Inhaber N, Jalan R. Corrigendum to "Alfapump(R) system vs. large volume paracentesis for refractory ascites: A multicenter randomized controlled study" [J Hepatol 67 (2017) 940-949]. J Hepatol. 2018 Mar;68(3):630. doi: 10.1016/j.jhep.2017.12.017. Epub 2018 Feb 1. No abstract available.

Reference Type: BACKGROUND

PMID: 29395458 (View on PubMed)

Stirnimann G, Berg T, Spahr L, Zeuzem S, McPherson S, Lammert F, Storni F, Banz V, Babatz J, Vargas V, Geier A, Stallmach A, Engelmann C, Trepte C, Capel J, De Gottardi A. Treatment of refractory ascites with an automated low-flow ascites pump in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Nov;46(10):981-991. doi: 10.1111/apt.14331. Epub 2017 Sep 21.

Reference Type: BACKGROUND

PMID: 28940225 (View on PubMed)

Lai JC, Covinsky KE, Dodge JL, Boscardin WJ, Segev DL, Roberts JP, Feng S. Development of a novel frailty index to predict mortality in patients with end-stage liver disease. Hepatology. 2017 Aug;66(2):564-574. doi: 10.1002/hep.29219. Epub 2017 Jun 28.

Reference Type: BACKGROUND

PMID: 28422306 (View on PubMed)

Chang L, Ni J, Zhu Y, Pang B, Graham P, Zhang H, Li Y. Liquid biopsy in ovarian cancer: recent advances in circulating extracellular vesicle detection for early diagnosis and monitoring progression. Theranostics. 2019 May 31;9(14):4130-4140. doi: 10.7150/thno.34692. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31281536 (View on PubMed)

Palmirotta R, Lovero D, Cafforio P, Felici C, Mannavola F, Pelle E, Quaresmini D, Tucci M, Silvestris F. Liquid biopsy of cancer: a multimodal diagnostic tool in clinical oncology. Ther Adv Med Oncol. 2018 Aug 29;10:1758835918794630. doi: 10.1177/1758835918794630. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30181785 (View on PubMed)

Giannopoulou L, Kasimir-Bauer S, Lianidou ES. Liquid biopsy in ovarian cancer: recent advances on circulating tumor cells and circulating tumor DNA. Clin Chem Lab Med. 2018 Jan 26;56(2):186-197. doi: 10.1515/cclm-2017-0019.

Reference Type: BACKGROUND

PMID: 28753534 (View on PubMed)

Other Identifiers

2018-AAR-013

Identifier Type: -

Identifier Source: org_study_id