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NCT02400164 · ClinicalTrials.gov registry record · NA
A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites
A NA study of Cirrhosis and Ascites, sponsored by Sequana Medical N.V..
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT02400164: Completed NA study of Cirrhosis and Ascites, sponsored by Sequana Medical N.V..
NCT02400164 is a NA study of Cirrhosis and Ascites that has completed, run by Sequana Medical N.V.. The registered enrollment target is 30 participants, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02400164, a NA study of Cirrhosis and Ascites, has completed, sponsored by Sequana Medical N.V..
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial analysis after 3 months. Extended follow-up for safety monitoring purposes will continue for the lifetime of the patient or until the device is explanted.
Interventions
- DEVICE alfapump system
Study Locations (6)
Virginia
- University of Virginia - Charlottesville
- VCU Medical Centre - Richmond
California
- California Pacific Medical - San Francisco
Minnesota
- Mayo Clinic - Rochester
Texas
- Baylor University Healthcare System - Dallas
Ontario
- Toronto General Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-03-31 |
| Phase | NA |
What the finished NCT02400164 record still lists
NCT02400164 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 90,408-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Cirrhosis appearing as the primary indexed condition, and to 1 intervention - of which alfapump system is the first listed.
NCT02400164 lists 6 locations in 5 states (Virginia, California, Minnesota).
Frequently Asked Questions
What is clinical trial NCT02400164 about?
NCT02400164 is a clinical study titled "A (M)Ulti-center, Prospective, (O)Pen Label, Uncontrolled Feasibility (S)Tudy to Assess the Safety and Effectiveness of an Automatic Low Flow (A)Scites (Alfa) Pump (I)n Patients With (C)Irrhosis and Refractory or Recurrent Ascites". The study is a multi-center, prospective, open label, uncontrolled feasibility study enrolling 30 patients with refractory or recurrent ascites and cirrhosis at up to 6 sites. Patients will be enrolled during a 6 month enrollment phase after which data will be collected for 12months with an initial ...
What is the current status of trial NCT02400164?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2015-03. Estimated completion is 2018-03-31.
What conditions does trial NCT02400164 study?
This clinical trial studies the following conditions: Cirrhosis, Ascites.
What interventions are being tested in trial NCT02400164?
The interventions under investigation include: alfapump system (DEVICE).
Who is sponsoring clinical trial NCT02400164?
This trial is sponsored by Sequana Medical N.V., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02400164 being conducted?
This trial has 6 study locations across California, Minnesota, Texas, Virginia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02400164's enrollment target sits among peer trials
30 31st of 53 higher than 13 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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