NCT06996379 · Northwestern University
J-Tip Use for Paracentesis in Adults With Ascites
What this study is about
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.
View original scientific description
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 to have this procedure performed again. There is also a telephone follow-up survey 2 days after the procedure to ask the participant about their experience post-procedure. We will also collect data about any procedure complications.
Interventions
DEVICE
Experimental J-Tip Needle-Free Injection System
This experimental intervention arm will include use of the J-Tip needle-less device to administer a one-time dose of 1% lidocaine during the superficial (intradermal) numbing step of a bedside abdominal paracentesis for adults with cirrhosis of the liver and ascites requiring bedside paracentesis.
DEVICE
Control (Standard treatment)
The control intervention arm will include use of a 25-gauge needle (standard of care) to administer a one-time dose of 1% lidocaine during the superficial (intradermal) numbing step of a bedside abdominal paracentesis for adults with cirrhosis of the liver and ascites requiring bedside paracentesis.
Primary outcome measures
Pain during intra-dermal (superficial) local anesthetic administration
Time frame: From enrollment to end of procedure (approximately 2 hours).
We seek to investigate the use of the J-Tip Needle-Free Injection System during bedside abdominal paracentesis in improving patient tolerance of the local anesthetic process and the procedure. Following the procedure, the patient will be asked by a study coordinator (in person or over the phone) to rate their pain using a numeric rating scale (NRS from 1 to 10; 0= no pain, 10 = extreme pain).
Pain during subcutaneous local anesthetic administration
Time frame: From enrollment to end of procedure (approximately 2 hours).
We seek to investigate the use of the J-Tip Needle-Free Injection System during bedside abdominal paracentesis in improving patient tolerance of the local anesthetic process and the procedure. Following the procedure, the patient will be asked by a study coordinator (in person or over the phone) to rate their pain using a numeric rating scale (NRS from 1 to 10; 0= no pain, 10 = extreme pain).
Pain during paracentesis
Time frame: From enrollment to end of procedure (approximately 2 hours).
We seek to investigate the use of the J-Tip Needle-Free Injection System during bedside abdominal paracentesis in improving patient tolerance of the local anesthetic process and the procedure. Following the procedure, the patient will be asked by a study coordinator (in person or over the phone) to rate their pain using a numeric rating scale (NRS from 1 to 10; 0= no pain, 10 = extreme pain).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \- Adult (age \> 18 years) patients in the emergency department or admitted to the general medical service at Northwestern Memorial Hospital who:
- Have cirrhosis and ascites
- Require diagnostic and/or therapeutic paracentesis as determined by their primary physician
- 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:
- Procedure deemed unsafe due to insufficient ascites/suboptimal location of ascites as evaluated by ultrasound
- Cellulitis overlying the site of aspiration
- Do not speak English as a preferred language
- Are prisoners
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations