Malignant AscitesNCT03200106
Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites
An observational study of Malignant Ascites, run by Sequana Medical N.V. at 3 sites in 3 countries.
Trial summary
Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature. 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
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Aug 2017to 31 Mar 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: A total of up to 20 patients' charts who have previously been treated with alfapump will be reviewed.
Who may be able to join
- Patients with malignant ascites
- Patients with alfapump implanted for malignant ascites
- Patients 18 years or older at the time of death
Who cannot join
- Patient is alive at the time of inclusion assessment
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature.
This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.
- Conditions
- Malignant Ascites
- Being tested
- Alfapump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfapumpDevice
Alfapump implant
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of LVP after implantation of the alfapump
The primary objective of the study is to evaluate the performance of the alfapump in reducing the need for large volume paracentesis (LVP) defined as paracentesis of five or more litres of ascites and not by pump paracentesis.
Measured: 3-6 months post implant
Secondary outcomes (1)
The safety and tolerability of alfapump in patients with malignant ascites
Device, procedure and therapy related AEs and SAEs
Measured: 3-6 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Aug 2017
- Primary completion28 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequana Medical N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeroen Capel, MSc, Study director, Sequana MedicalChristina Fotopoulou, Ph.D, Principal investigator, Hammersmith Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200106
- Sponsor's protocol ID
- 2017-AAR-011
- Status last verified
- Apr 2018
- First submitted
- 23 Jun 2017
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fotopoulou C, Berg T, Hausen A, Hennig R, Jalan R, Malago M, Capel J, De Gottardi A, Stirnimann G. Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites. BMC Palliat Care. 2019 Dec 5;18(1):109. doi: 10.1186/s12904-019-0497-3.
PubMed 31805921
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study in the Use of the Alfapump and the Treatment of Malignant Ascites
- ClinicalTrials.gov ID
- NCT03200106
- Acronym / sponsor ID
- 2017-AAR-011
- Conditions
- Malignant Ascites
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sequana Medical N.V.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of malignant ascites with the alfapump offers a new treatment option for this patient group. So far, there is no systematic analysis of patients with this indication available in the literature.
This retrospective analysis offers the possibility to assemble already existing data within a reasonably short time frame. Based on this analysis, a prospective analysis can be designed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of up to 20 patients' charts who have previously been treated with alfapump will be reviewed.
Key inclusion criteria (3 listed)
- Patients with malignant ascites
- Patients with alfapump implanted for malignant ascites
- Patients 18 years or older at the time of death
Key exclusion criteria (1 listed)
- Patient is alive at the time of inclusion assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfapumpAlfapump implant | Device | – |
Primary outcome
Change in frequency of LVP after implantation of the alfapump
Time frame: 3-6 months post implant
The primary objective of the study is to evaluate the performance of the alfapump in reducing the need for large volume paracentesis (LVP) defined as paracentesis of five or more litres of ascites and not by pump paracentesis.
1 secondary outcome
The safety and tolerability of alfapump in patients with malignant ascites
Time frame: 3-6 months post implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Derived from this study: PubMed 31805921Fotopoulou C, Berg T, Hausen A, Hennig R, Jalan R, Malago M, Capel J, De Gottardi A, Stirnimann G. Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites. BMC Palliat Care. 2019 Dec 5;18(1):109. doi: 10.1186/s12904-019-0497-3.
- Individual participant dataSharing planned: Undecided
Related trials for Malignant Ascites
RecruitingPhase 1/2
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Retlirafusp Alfa Plus SOX and Intraperitoneal Nab-Paclitaxel for Advanced Gastric/GEJ Cancer With Malignant Ascites
Gastric Cancer (GC), Peritoneal Metastases From Gastric Cancer
RecruitingObservational study
Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites
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RecruitingPhase 1
TLR9 Immunotherapy for Peritoneal Carcinomatosis
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Not yet recruitingEarly Phase 1
NK521 in the Treatment of Advanced Solid Tumors
Hepatocellular Carcinoma (HCC), Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Capel, MSc study director
Sequana Medical
Christina Fotopoulou, Ph.D principal investigator
Hammersmith Hospitals NHS Trust
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Ascites, run by Sequana Medical N.V. at 3 sites in 3 countries.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Switzerland, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in frequency of LVP after implantation of the alfapump (time frame: 3-6 months post implant). 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 NCT03200106, which also lists 1 linked publication.
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 9 Apr 2018.