Clinical trial · Interventional
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)
NCT07490626CI-TRIAL-00121945ParacentesisrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Ascites | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| At-home Paracentesis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- At-home Paracentesis
- description
- Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility.
- interventionNames
- Procedure: At-home Paracentesis
Primary outcomes (1)
- 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.
- timeFrame
- 3 months
- description
- 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 (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.