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

Официальное название

A Pilot Study of At-Home Paracentesis for Women With Cancer-Related Malignant Ascites: A Decentralized Interventional Treatment Trial (Paracentesis)

Обзор

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

Вмешательства

• Процедура At-home Paracentesis
  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.

Первичные конечные точки

• The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis. [Срок оценки: 3 months]

Вторичные конечные точки (6)

• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type. [Срок оценки: 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). [Срок оценки: 3 months]
• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness. [Срок оценки: 3 months]
• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration. [Срок оценки: 3 months]
• The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention. [Срок оценки: 3 months]
• The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion. [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Female aged ≥ 18 years
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Huntsman Cancer Institute at the University of Utah — Salt Lake City

Идентификаторы

NCT: NCT07490626 · HCI198711

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗