NCT07490626招募中不适用
A Pilot Study of At-Home Paracentesis for Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
研究概览
简要总结
The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
At-home Paracentesis
Experimental
Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility.
干预措施: At-home Paracentesis (Procedure)
结局指标
主要结局
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
时间窗: 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.
The change in the 3-item AIM-TSS from before at-home paracentesis to after at-home paracentesis.
时间窗: 3 months
To evaluate the change in symptoms in patients who complete at-home paracentesis.
次要结局
- 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)
研究者
研究点 (2)
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