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Search / Trial NCT06996379

J-Tip Use for Paracentesis in Adults With Liver Cirrhosis and Ascites

Launched by NORTHWESTERN UNIVERSITY · May 21, 2025

Trial Information

Current as of August 24, 2025

Recruiting

Keywords

J Tip Needle Less Device Needle Free Device Paracentesis Comfort Numbing Level Of Comfort Procedure Related Pain

ClinConnect Summary

This clinical trial is studying how comfortable adults with liver cirrhosis and fluid build-up (known as ascites) feel during a procedure called paracentesis, which involves removing excess fluid from the abdomen. The trial is comparing two methods of numbing the skin before this procedure: using a traditional needle versus a needle-less device called the J-Tip. Researchers want to know if using the J-Tip results in less pain and anxiety for patients during the numbing process and the paracentesis itself.

To participate, you need to be an adult over 18 years old who has liver cirrhosis and ascites and requires a paracentesis. You'll be randomly chosen to receive either the needle or the J-Tip for numbing. After the procedure, you'll fill out a survey about your pain and comfort, and a follow-up call will check in on your experience two days later. The trial is currently looking for participants at Northwestern Memorial Hospital, and it aims to improve the comfort of patients undergoing this important procedure.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • - Adult (age \> 18 years) patients in the emergency department or admitted to the general medical service at Northwestern Memorial Hospital who:
  • 1. Have cirrhosis and ascites
  • 2. Require diagnostic and/or therapeutic paracentesis as determined by their primary physician
  • 3. Have capacity as determined by their ED or inpatient provider to consent for the procedure
  • c. Speak English as a preferred language
  • Exclusion Criteria:
  • Have ever received chemotherapy, as this is a contra-indication to J-Tip use
  • Lack capacity to consent for the procedure and/or capacity to rate their pain using the numeric pain rating scale
  • * Have a contraindication to bedside paracentesis, including:
  • 1. Procedure deemed unsafe due to insufficient ascites/suboptimal location of ascites as evaluated by ultrasound
  • 2. Cellulitis overlying the site of aspiration
  • 3. Pregnancy
  • Do not speak English as a preferred language
  • Are prisoners

About Northwestern University

Northwestern University is a prestigious academic institution renowned for its commitment to advancing medical research and improving patient care through innovative clinical trials. With a robust infrastructure that supports interdisciplinary collaboration, Northwestern leverages its expertise in various fields, including medicine, engineering, and social sciences, to drive groundbreaking studies. The university is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring that all clinical trials are conducted with the utmost integrity and focus on participant safety. Through its Clinical Trials Office, Northwestern aims to translate scientific discoveries into effective therapies, ultimately enhancing health outcomes and contributing to the broader medical community.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Emily Kahn, MD

Principal Investigator

Northwestern University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported