NCT06996379 J-Tip Use for Paracentesis in Adults With Ascites
| NCT ID | NCT06996379 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwestern University |
| Condition | Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-05-20 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Emily Kahn, MD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06996379 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06996379 currently recruiting?
Yes, NCT06996379 is actively recruiting participants. Contact the research team at emily.kahn@nm.org for enrollment information.
Where is the NCT06996379 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06996379 clinical trial?
NCT06996379 is sponsored by Northwestern University. The principal investigator is Emily Kahn, MD at Northwestern University. The trial plans to enroll 110 participants.