Malignant AscitesParacentesisNCT07490626
At-Home Paracentesis for Cancer-Related Malignant Ascites (Paracentesis)
A study testing At-home Paracentesis in people with Malignant Ascites, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- At-home Paracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Susan Sharry, 801-585-3453, Susan.sharry@hci.utah.edu
About this study
Official title: A Pilot Study of At-Home Paracentesis for Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)
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
- Being tested
- At-home Paracentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home ParacentesisProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| At-home Paracentesis | Experimental | Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. Receives: Procedure: At-home Paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess the safety and tolerability of at-home paracentesis.
Measured: 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).
To assess the safety and tolerability of at-home paracentesis.
Measured: 3 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety and tolerability of at-home paracentesis.
Measured: 3 months
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety and tolerability of at-home paracentesis.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start15 Sep 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Beck, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490626
- Sponsor's protocol ID
- HCI198711
- Acronym
- Paracentesis
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of At-Home Paracentesis for Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)
- ClinicalTrials.gov ID
- NCT07490626
- Acronym / sponsor ID
- Paracentesis / HCI198711
- Conditions
- Malignant Ascites
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At-home Paracentesis | Experimental | Procedure: At-home ParacentesisParticipants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-home ParacentesisParacentesis 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. | Procedure or surgery | At-home Paracentesis |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Beck, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At-home Paracentesis in people with Malignant Ascites, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Sharry (801-585-3453, susan.sharry@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.