RECRUITING

J-Tip Use for Paracentesis in Adults With Liver Cirrhosis and Ascites

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Use of the J-Tip Needle-Free Injection System With 1% Lidocaine to Reduce Paracentesis-Related Discomfort

Quick Facts

Study Start:2025-05-20
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06996379

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have cirrhosis and ascites
  2. 2. Require diagnostic and/or therapeutic paracentesis as determined by their primary physician
  3. 3. Have capacity as determined by their ED or inpatient provider to consent for the procedure
  1. * Have ever received chemotherapy, as this is a contra-indication to J-Tip use
  2. * Lack capacity to consent for the procedure and/or capacity to rate their pain using the numeric pain rating scale
  3. * Have a contraindication to bedside paracentesis, including:
  4. 1. Procedure deemed unsafe due to insufficient ascites/suboptimal location of ascites as evaluated by ultrasound
  5. 2. Cellulitis overlying the site of aspiration
  6. 3. Pregnancy
  7. * Do not speak English as a preferred language
  8. * Are prisoners

Contacts and Locations

Study Contact

Emily Kahn, MD
CONTACT
(312) 926-5924
emily.kahn@nm.org
Christina Wing, BS
CONTACT
(312) 926-0042
christina.wing@northwestern.edu

Principal Investigator

Emily Kahn, MD
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Emily Kahn, MD, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-05-20
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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