Malignant Ascites Alfapump® Study

NCT04076566 | Withdrawn DMC

• 1 other identifier: 2018-AAR-013
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Ascites

Keywords

OVARIAN; COLORECTAL; PARACENTESIS

Outcome Measures

Primary Outcomes (1)

• Monthly therapeutic paracentesis frequency up to 3 months

  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.

  3 months post-implantation

Secondary Outcomes (23)

• Monthly therapeutic paracentesis frequency up to 6 months

  6 months post-implantation

• Safety outcome: free survival

  Time (days) to first paracentesis after implantation through 270 days post 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

• Efficacy outcome- Assessment of changes in Quality of Life

  at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline

• Efficacy outcome- Assessment of changes in Quality of Life

  at 1-month, 3-month, 6-month and 9-month follow-up compared to baseline

Other Outcomes (2)

• Exploratory outcome- liquid biopsies

  2-days, 7-days, 3-months, 6-months and 9-months post implant

• Exploratory outcome - anticancer treatment

  Time (days) to event through study completion up to 270 days post-pump implantation

Interventions

alfapump system DEVICE

active implantable device for treatment of malignant ascites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sequana Medical N.V.: lead

Study Sites (1)

Hammersmith Hospital

London, W120HS, United Kingdom

Location

Related Publications (13)

• 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.

  PMID: 20633946 BACKGROUND

• 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.

  PMID: 15740535 BACKGROUND

• 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.

  PMID: 16185942 BACKGROUND

• 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.

  PMID: 3360270 BACKGROUND

• 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.

  PMID: 7516361 BACKGROUND

• 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.

  PMID: 8831595 BACKGROUND

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

  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.

  PMID: 29395458 BACKGROUND

• 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.

  PMID: 28940225 BACKGROUND

• 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.

  PMID: 28422306 BACKGROUND

• 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.

  PMID: 31281536 BACKGROUND

• 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.

  PMID: 30181785 BACKGROUND

• 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.

  PMID: 28753534 BACKGROUND

Study Officials

• Christina Fotopoulou, Prof, MD

  Imperial Hospital, London, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: September 3, 2019
• Study Start: May 31, 2020
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: August 10, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)