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NCT Number: NCT07490626

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location contact

Susan Sharry

CONTACT

[email protected]

801-585-3453

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

At-home Paracentesis

Procedure

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 outcomes

  1. 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

    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.

Secondary outcomes

  1. The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.

    Time frame: 3 months

    To assess the safety and tolerability of at-home paracentesis.

  2. 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

    To assess the safety and tolerability of at-home paracentesis.

  3. The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.

    Time frame: 3 months

    To assess the safety and tolerability of at-home paracentesis.

  4. The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.

    Time frame: 3 months

    To assess the safety and tolerability of at-home paracentesis.

  5. The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.

    Time frame: 3 months

    To assess the safety and tolerability of at-home paracentesis.

  6. The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.

    Time frame: 3 months

    To assess the rate of procedure-related complications after at-home paracentesis.

Study contacts

Contact information is provided by the study sponsor or research team.

Susan Sharry

CONTACT

[email protected]

801-585-3453

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: Paracentesis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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