Health TrialsbyHealthPanel

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

ConditionMalignant Ascites
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah

About this trial

The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged ≥ 18 years

Able to speak and understand English.

Has completed an initial clinic-based paracentesis procedure.

Confirmed diagnosis of cancer.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • At-home Paracentesis

    Procedure/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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: At-home ParacentesisExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Source ClinicalTrials.gov
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