ClinicalTrials.gg
RecruitingNCT07490626ParacentesisUpdated Sep 18, 2026

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

An interventional study of At-home Paracentesis in Malignant Ascites, sponsored by University of Utah. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by University of Utah · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Malignant Ascites

Browse trials for

03

In context

Ascites

247 studies on the registry are indexed under Ascites; 57 are open to participants now.

This study's planned enrollment of 20 is below the median of 54 across 179 interventional studies indexed under Ascites.

Browse Ascites studies →

Lead sponsor

University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.

Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , participant is following standard of care guidelines for .
  • Able to provide and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion criteria

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 , comply with the study protocol or complete the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    At-home Paracentesis

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

    Procedure: At-home Paracentesis

Interventions

  • ProcedureAt-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.

06

What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

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

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

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

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

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

    Time frame: 3 months

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

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

    Time frame: 3 months

  5. 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.

    Time frame: 3 months

  6. 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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Oct 2027, 13 months after the start.

Of 33 interventional studies with no phase under Ascites, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 62. This study's planned 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Mar 24, 2026
StartActual
Sep 15, 2026
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2028
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07490626
Lead sponsor
University of Utah
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Sep 15, 2026
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Sep 18, 2026

Study contacts

Susan Sharry
Contact
susan.sharry@hci.utah.edu
801-585-3453
Anna Beck, MD
principal investigator · Huntsman Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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