At-Home Paracentesis for Women With Cancer-Related Malignant Ascites (Paracentesis) (NCT07490626) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
At-Home Paracentesis for Women With Cancer-Related Malignant Ascites (Paracentesis)
United States20 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female aged ā„ 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.
What they're measuring
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.