Paracentesis en el Hogar para Mujeres con Ascitis Maligna Relacionada con Cáncer (Paracentesis) (Paracentesis)
Un Estudio Piloto de Paracentesis en el Hogar para Mujeres con Ascitis Maligna Relacionada con Cáncer: Un Ensayo de Tratamiento Intervencionista Descentralizado (Paracentesis)
The goal of this study is to evaluate the change in symptoms for cancer-related malignant ascites who complete an at-home paracentesis procedure.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Susan Sharry
- Número de teléfono: 801-585-3453
- Correo electrónico: susan.sharry@hci.utah.edu
Ubicaciones de estudio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Reclutamiento
- Huntsman Cancer Institute at the University of Utah
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Contacto:
- Susan Sharry
- Número de teléfono: 801-585-3453
- Correo electrónico: Susan.sharry@hci.utah.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: At-home Paracentesis
Participants receive an at-home-based paracentesis procedure, which may occur anytime following confirmation of eligibility. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change in the 3-item AIM (Ascites Impact Measure)-TSS (Total Symptom Score) from before at-home paracentesis to after at-home paracentesis.
Periodo de tiempo: 3 months
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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. |
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Periodo de tiempo: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
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).
Periodo de tiempo: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Periodo de tiempo: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Periodo de tiempo: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to the study intervention.
Periodo de tiempo: 3 months
|
To assess the safety and tolerability of at-home paracentesis. |
3 months
|
|
The rate of procedure-related complications, including pain, bleeding, infection, and volume depletion.
Periodo de tiempo: 3 months
|
To assess the rate of procedure-related complications after at-home paracentesis. |
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anna Beck, MD, Huntsman Cancer Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HCI198711
Información sobre medicamentos y dispositivos, documentos del estudio
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