This trial is terminated!
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More info
You can access this
clinical trial
if you have
Cirrhosis, Ascites Hepatic or Ascites (Non-Malignant)
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

Insertion of a tunnelated peritoneal catheter (PleurX) allows repeated intermittent small volume fluid drainage at home. The treatment may improve the management of ascites and have a beneficial effect on the quality of life. This study aims to evaluate the beneficial and harmful effects of the peritoneal catheter (PleurX) versus repeated large volume paracentesis for patients with cirrhosis and diuretic resistant ascites. The trial is an investigator initiated, randomised, single blind, parallel arm, controlled trial. Tunnelated peritoneal (PleurX) catheter versus large volume paracentesis. All patients will receive ciprofloxacin to prevent spontaneous bacterial peritonitis. We will include 32 adult patients with cirrhosis Duration of trial 18 months. The total duration of follow up is six months. The primary outcome is paracentesis free survival.

Provided treatments

  • Device: PleurX, peritoneal tunnelated catheter
  • Device: Large Volume Paracentesis
  • Drug: Ciprofloxacin 500Mg Tablet

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT03027635. The sponsor of the trial is Nina Kimer and it is looking for 13 volunteers for the current phase.
Official trial title:
Tunnelated Peritoneal Catheter Versus Repeated Large Volume Paracentesis for Diuretic Resistant Ascites in Patients With Cirrhosis: An Investigator Initiated, Open, Parallel Arm Randomized Controlled Trial