NCT07490626

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
25mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Jul 2028

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 18, 2026

Last Update Submit

March 23, 2026

Conditions

Malignant Ascites

Outcome Measures

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.

    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 Outcomes (6)

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

    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).

    3 months

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

    3 months

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

    3 months

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

    3 months

  • +1 more secondary outcomes

Study Arms (1)

At-home Paracentesis

EXPERIMENTAL

Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility.

Procedure: At-home Paracentesis

Interventions

At-home ParacentesisPROCEDURE

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.

At-home Paracentesis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale aged ≥ 18 years
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

  • Anna Beck, MD

    Huntsman Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Sharry

CONTACT

801-585-3453susan.sharry@hci.utah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)