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

A Pilot Study of At-Home Paracentesis for Women With Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)

The goal of this study is to evaluate the change in symptoms for women with cancer-related malignant ascites who complete an at-home paracentesis procedure.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Ascites
• Intervention / Treatment: Procedure: At-home Paracentesis

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan Sharry; Phone Number: 801-585-3453; Email: susan.sharry@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at the University of Utah
      • Contact: Susan Sharry; Phone Number: 801-585-3453; Email: susan.sharry@hci.utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female aged ≥ 18 years
• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: At-home Paracentesis; Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility.	Procedure: At-home Paracentesis; Paracentesis is a bedside procedure to obtain ascitic fluid from the peritoneum through needle aspiration, performed for both diagnostic and therapeutic purposes. The procedure involves needle insertion into the peritoneal cavity to remove fluid for analysis or to relieve symptoms from tense ascites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.	To assess the safety and tolerability of at-home paracentesis.	3 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).	To assess the safety and tolerability of at-home paracentesis.	3 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.	To assess the safety and tolerability of at-home paracentesis.	3 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.	To assess the safety and tolerability of at-home paracentesis.	3 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.	To assess the safety and tolerability of at-home paracentesis.	3 months
The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.	To assess the rate of procedure-related complications after at-home paracentesis.	3 months

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Anna Beck, MD, Huntsman Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HCI198711

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No