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Malignant AscitesProMASNCT04076566

Malignant Ascites Alfapump® Study

An observational study of Malignant Ascites, run by Sequana Medical N.V. at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Ascites
What is being tested?
alfapump system
Type of treatment
Medical device
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
31 May 2020to Mar 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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) .
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hammersmith Hospital

    London, W120HS

Other trials in United Kingdom

About this study

Official title: Prospective Study in the Use of the Alfapump® in the Treatment of Malignant Ascites

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.

Read the 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.

Being tested
alfapump system
Keywords
OVARIAN, COLORECTAL, PARACENTESIS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alfapump systemDevice

    active implantable device for treatment of malignant ascites

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months post-implantation

Secondary outcomes (23)

  1. Monthly therapeutic paracentesis frequency up to 6 months

    Monthly therapeutic paracentesis frequency up to 6 months compared to the baseline therapeutic paracentesis frequency.

    The monthly therapeutic paracentesis frequency at 6 months is defined as the average rate of therapeutic paracenteses during months 1 to 6 Baseline therapeutic paracentesis frequency is defined as the average rate of therapeutic paracentesis in the 3 months prior to pump implantation.

    Measured: 6 months post-implantation

  2. Safety outcome: free survival

    Therapeutic paracentesis free survival after Alfapump® implantation

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

  3. Efficacy outcome- Assessment of changes in Quality of Life

    Changes in Quality of life after Alfapump® implantation, measured with validated EORTC cancer related Quality of life Questionnaire-CR29 (ColoRectal 29 questions) in subjects with colorectal malignancy.

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

  4. Efficacy outcome- Assessment of changes in Quality of Life

    Changes in Quality of life after Alfapump® implantation assessed with validated FACIT-AI 5Ascites Index) ascites related quality of life questionnaire in all subjects enrolled in the study.

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

  5. Efficacy outcome- Assessment of changes in Quality of Life

    Changes in Quality of life after Alfapump® implantation, measured with validated EORTC-cancer related Quality of life questionnaire-OV28 (OVarian 28 questions), in subjects with a gynaecological malignancy.

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

  6. Nutritional status outcome

    Change in nutritional status assessed by Psoas muscle measurement

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

  7. Nutritional status outcome

    Change in nutritional status assessed by changes in serum Zinc

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

  8. Nutritional status outcome

    Change in nutritional status assessed by changes in serum pre-albumin

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

  9. Nutritional status outcome

    Change in nutritional status assessed by changes in serum phosphate

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

  10. Nutritional status outcome

    Change in nutritional status assessed by changes in serum potassium

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

  11. Nutritional status outcome

    Change in nutritional status assessed by changes in serum albumin

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

  12. Pump performance

    Total Monthly volume of ascitic fluid removed (sum of volumes removed during each month via either Alfapump® and via therapeutic paracentesis)

    Measured: at 1-month, 3-month, 6-month and 9-month follow-up

  13. Pump performance outcome - pump survival

    Pump survival through study completion, up to 270 days post-pump implantation

    Measured: Time (days) from implantation until explantation due to technical causes through study completion up to 270 days post-pump implantation

  14. Pump performance outcome - pump survival

    Pump survival through study completion, up to 270 days post-implantation

    Measured: Time (days) from implantation until first exchange due to technical causes through study completion up to 270 days post-pump implantation

  15. Pump performance outcome

    Frequency of hospitalisations following Alfapump® implantation through study completion up to 270 days post-pump implantation

    Measured: through study completion up to 270 days post-pump implantation

  16. Pump performance outcome

    Duration of hospitalisations following Alfapump® implantation through study completion up to 270 days post-pump implantation

    Measured: throug study completion up to to 270 days post-pump implantation

  17. Safety outcome - subject survival

    Subject overall survival after Alfapump® implantation through study completion up to 270 days post-pump implantation

    Measured: Time (days) until exitus through study completion up to 270 days post-pump implantation

  18. Safety outcome- Bladder metastasis: Freedom from metastatic bladder wall infiltration

    Freedom from metastatic bladder wall infiltration as assessed by cystoscopy

    Measured: at 6-month follow-up

  19. Safety outcome- Worsening of renal function

    Incidence of subjects suffering Renal function deterioration, defined as a rise in serum creatinine of ≥50% or ≥0.3mg/dl .

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

  20. Safety outcome- Incidence of device related infection

    Incidence of Device-related infections following pump-implantation

    Measured: at 3-month, 6-month and 9-month follow-up

  21. Safety outcome- Incidence of Procedure related events

    Incidence of Procedure related adverse events

    Measured: At 1 month follow-up.

  22. Safety outcome- Incidence of Device related events

    Incidence of any Device-related adverse events

    Measured: at 3-month, 6-month and 9-month follow-up

  23. Device failure

    Incidence of device failure resulting in re-intervention (Revision, exchange or explantation) through study completion up to 270 days post-pump implantation

    Measured: Through study completion up to 270 days post-pump implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2019
  2. Study start31 May 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionMar 2022 (estimated)

Why it stopped: Update to clinical strategy - COVID impact

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04076566
Sponsor's protocol ID
2018-AAR-013
Acronym
ProMAS
Status last verified
Aug 2019
First submitted
2 Aug 2019
Last updated
10 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared with other researchers

Publications

  • 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.

    PubMed 20633946

  • 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.

    PubMed 15740535

  • 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.

    PubMed 16185942

  • 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.

    PubMed 3360270

  • 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.

    PubMed 7516361

  • 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.

    PubMed 8831595

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

  • 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.

    PubMed 29395458

  • 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.

    PubMed 28940225

  • 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.

    PubMed 28422306

  • 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.

    PubMed 31281536

  • 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.

    PubMed 30181785

  • 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.

    PubMed 28753534

Questions about this trial

What is this clinical trial studying?

An observational study of Malignant Ascites, run by Sequana Medical N.V. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monthly therapeutic paracentesis frequency up to 3 months (time frame: 3 months post-implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04076566, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.

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