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J-Tip Use for Paracentesis in Adults With Ascites

RecruitingNAAges 18 Years - anyAllNorthwestern University
NCT06996379 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to evaluate the level of comfort adult patients with cirrhosis of the liver and ascites presenting to Northwestern Memorial Hospital experience during a bedside abdominal paracentesis by numbing the skin with a needle-less device (the J-Tip), instead of using a needle to numb the skin. The main questions it aims to answer are the J-Tip effect upon: 1. Pain during intra-dermal local anesthetic administration 2. Pain during subcutaneous local anesthetic administration 3. Pain during paracentesis 4. Procedure-related anxiety Participants will be randomly assigned to have their skin numbed either in the usual way with a needle or with the J-Tip. Participants will be responsible for having a paracentesis done in their hospital room and answering the survey questions regarding pain experienced during the procedure and how they would feel if they needed t

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📋 Eligibility rules (as published)
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
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What it tests

  • Experimental J-Tip Needle-Free Injection System
  • Control (Standard treatment)
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Where

1 site
Northwestern Memorial Hospital
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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