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

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.

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.