At-Home Paracentesis for Malignant Ascites

This study is looking at how an at-home paracentesis procedure affects symptoms for women with cancer-related malignant ascites (fluid buildup in the abdomen). Paracentesis is a procedure where a needle is used to remove this fluid. You may be able to join if you are a woman aged 18 or older, have a confirmed cancer diagnosis, and have already had an initial paracentesis in a clinic. The study will measure changes in your symptoms using a special score called the AIM-TSS (Ascites Impact Measure-Total Symptom Score) over 3 months to see if the at-home procedure helps. The current status of this study is unclear, and it plans to enroll 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific procedure. It plans to enroll 20 women.
What's involved
You would undergo an at-home paracentesis procedure. The study will measure your symptoms before and after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured for 3 months after the at-home paracentesis procedure.

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NCT07490626

At-Home Paracentesis for Cancer-Related Malignant Ascites (Paracentesis)

Not Yet Recruiting
NAAges 18+InterventionalTreatment
University of Utah
~20 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:At-home Paracentesis

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
Measured over 3 months
Malignant Ascites
1 sites across 1 states
Utah1
  • Anna Beck, MD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

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Eligibility criteria

Inclusion

Participants aged ≥ 18 years
Able to speak and understand English.
Has completed an initial clinic-based paracentesis procedure.
Confirmed diagnosis of cancer.
Symptoms related to ascites requiring procedure in the opinion of the investigator.
Eligible to receive an ultrasound-guided paracentesis procedure at home in the opinion of the investigator.
If applicable, participant is able to safely hold anticoagulant therapy per institutional standards prior to the procedure in the opinion of the investigator.
For participants of child-bearing potential, participant is following standard of care guidelines for contraception.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion

Rapidly deteriorating condition or suspected bowel obstruction.
Large ventral hernias or prior complications from paracentesis.
Need for concurrent procedures requiring hospital resources.
Known lack of safe environment or inability to obtain sterile conditions at home.
Any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the procedure or clinical study due to safety concerns or compliance with clinical study procedures. For example,
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
  • The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.3 months

    To evaluate the change in symptoms in patients who complete at-home paracentesis. The AIM survey consists of 3 questions from 0 (No Symptoms) to 5 (Very Severe). A lower score is better. At the end of the study, all the results will be added together for the TSS. A lower score is preferred to show a positive outcome.