Menu
Not yet recruiting NCT07490626

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

No phase Interventional Malignant Ascites

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: At-home Paracentesis.
Who it may be relevant to
Registry conditions: Malignant Ascites. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis. [Time frame: 3 months]
Secondary outcome measures (6)
  • The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type. [Time frame: 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). [Time frame: 3 months]
  • The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness. [Time frame: 3 months]
  • The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration. [Time frame: 3 months]
  • The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention. [Time frame: 3 months]
  • The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion. [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Huntsman Cancer Institute at the University of Utah — Salt Lake City

Identifiers

NCT: NCT07490626 · HCI198711

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗