Using a needle-free device for numbing skin during paracentesis in liver cirrhosis patients
Official title: Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort
Run by Northwestern University · NCT06996379 · Data updated 2026-11-12
This study is testing a needle-free device to see if it can make the skin numbing process more comfortable for adults with liver cirrhosis who need a procedure to remove fluid from their abdomen.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT06996379 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with cirrhosis and ascites requiring bedside paracentesis.
✕Probably not a fit
Patients who have received chemotherapy or have contraindications to paracentesis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the comfort level of adult patients with liver cirrhosis and ascites during abdominal paracentesis when using a needle-less device (J-Tip) for numbing the skin, compared to the traditional needle method. Participants will be randomly assigned to receive either the J-Tip or standard needle-based local anesthetic before the procedure. The study aims to assess pain levels during the administration of local anesthetics and the paracentesis itself, as well as any procedure-related anxiety. A follow-up survey will be conducted two days post-procedure to gather additional feedback on patient experiences.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and anxiety for patients undergoing paracentesis.
How similar studies have gone: While the use of needle-free devices is gaining interest, this specific application in paracentesis has not been widely tested, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Northwestern Memorial Hospital
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Emily Kahn, MD — Northwestern University
- Study coordinator: Emily Kahn, MD
- Email: emily.kahn@nm.org
- Phone: (312) 926-5924
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.