Recruiting

J-Tip

Sponsor:

Northwestern University

Code:

NCT06996379

Conditions

Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Experimental J-Tip Needle-Free Injection System

Control (Standard treatment)

Study Details

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.

Conditions

Evaluate Patient Comfort Level During Paracentesis by Numbing Skin With a Needle-less Device, Instead of Using a Needle to Numb the Skin

Study ID

NCT06996379

Start date

May 20, 2025

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Control (25-gauge Needle) Arm, Current Standard of Care

During abdominal paracentesis lidocaine will be administered superficially (intradermally) via a 25-gauge intradermal needle (control), as per the current standard of care.

experimental: Experimental (J-Tip device) Arm

During abdominal paracentesis lidocaine will be administered superficially (intradermally) via needle-free injection system (the J-Tip device). This is the experimental arm to compare to the 25-gauge needle (standard of care) method of intradermal lidocaine administration during abdominal paracentesis.

Interventions

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.

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 measure

  • Pain during intra-dermal (superficial) local anesthetic administration [ Time Frame: From enrollment to end of procedure (approximately 2 hours). ]
  • Pain during subcutaneous local anesthetic administration [ Time Frame: From enrollment to end of procedure (approximately 2 hours). ]
  • Pain during paracentesis [ Time Frame: From enrollment to end of procedure (approximately 2 hours). ]

Central Contacts and Locations

Central contacts

Emily Kahn, MD

(312) 926-5924emily.kahn@nm.org

Christina Wing, BS

(312) 926-0042christina.wing@northwestern.edu

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Emily Kahn, MD

(312) 926-5924emily.kahn@nm.org

Christina Wing, BS

(312) 926-0042christina.wing@northwestern.edu

Principal Investigator:

Emily Kahn, MD

More Information

Sponsor

Northwestern University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • J-Tip
  • needle-less device
  • needle-free device
  • paracentesis
  • comfort
  • numbing
  • level of comfort
  • procedure-related pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-04.