NCT07490626RecruitingNot Applicable
A Pilot Study of At-Home Paracentesis for Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
At-home Paracentesis
Experimental
Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility.
Intervention: At-home Paracentesis (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.(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).(3 months)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.(3 months)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.(3 months)
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.(3 months)
- The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.(3 months)
Investigators
Study Sites (1)
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