Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT07490626

Conditions

Malignant Ascites

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

At-home Paracentesis

Study Details

Brief summary:

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

Conditions

Malignant Ascites

Study ID

NCT07490626

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: At-home Paracentesis

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

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Susan Sharry

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

Locations

Huntsman Cancer Institute at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Susan Sharry

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

More Information

Sponsor

University of Utah

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of Utah on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.