Gastroenterostomía AXIOS™ para la obstrucción de la salida gástrica IDE
Un estudio prospectivo multicéntrico de un solo brazo de gastroenterostomía endoscópica guiada por ultrasonido con stent metálico de aposición de luz para la obstrucción de la salida gástrica por enfermedad maligna irresecable
To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is a prospective multi-center, single -arm study with treatment of up to 67 subjects at up to 10 clinical centers. Subjects who meet all eligibility criteria will receive the AXIOS stent and up to 12 months follow-up.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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São Paulo, Brasil, 01246-092
- Instituto do Cancer do Estado de Sao Paulo
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Leuven, Bélgica
- UZ Leuven
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Montreal, Canadá, H3Z 2E9
- McGill University Health Care
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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New York
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New York, New York, Estados Unidos, 10065
- New York Presbyterian/ Weill Cornell Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburg Medical Center
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Washington
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Seattle, Washington, Estados Unidos, 98101
- Virginia Mason Medical Center
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Hyderabad, India
- Asian Institute of Gastroenterology
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200433
- Shanghai Changhai Hospital
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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:
- Gastric outlet obstruction from unresectable malignant neoplasm
- Eligible for endoscopic intervention
- GOOS of 0 or 1 0 - no oral intake 1 - liquids only 2 - soft solids only 3 - low-residue or full diet
- 18 years of age or older
- Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
- The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm
Exclusion Criteria:
- Patients with baseline ECOG > 2 and/or Karnofsky Performance score < 30
- Gastric cancer or any malignant infiltration precluding a cancer free puncture site of the AXIOSTM stent
- Abnormal coagulation INR > 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation, and/or any underlying condition associated with high risk of bleeding
- Altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic gastroenterostomy
- Multiple-level bowel obstruction downstream from the intended location of the EUS-guided bypass confirmed by radiography such as small bowel series or computed tomography
- Presence of intraperitoneal fat between the gastric lumen and jejunal lumen estimated to be larger than 1.0 cm at the proposed site of AXIOSTM stent insertion
- Gastric varices located within a two-centimeter radius of the device insertion location on the gastric wall
- Ascites Grade ≥ 2 confirmed by cross-sectional imaging
- Vessels located within a two-centimeter radius of the device insertion location
- History of multiple abdominal surgeries and/or evidence of small bowel adhesions
- Allergic to any of the device materials
- Contraindications to use of electrical devices
- Pregnancy
- Prisoners and other vulnerable populations
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 |
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Experimental: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm |
Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serious Adverse Events
Periodo de tiempo: Through study completion, an average of 1 year
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The proportion of subjects with one or more AXIOS stent related or AXIOS endoscopic and/or study procedure related serious adverse events through 30 days post stent placement. |
Through study completion, an average of 1 year
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Technical Success
Periodo de tiempo: During the procedure
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The proportion of subjects that demonstrate technical Successful stent placement, defined as transmural placement of the AXIOS stent with confirmed stent patency by visualization of the contralateral wall of the small bowel through the AXIOS stent lumen. Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. Note: Visualization of blue dye in the gastric lumen or injection of contrast to confirm continuity of the gastroenteric lumen, may be used to provide supplemental confirmation of intended stent placement. |
During the procedure
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Primary Effectiveness Endpoint
Periodo de tiempo: through 14 days after procedure
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Clinical Success defined as improvement of Gastric Outlet Obstruction Score (GOOS)by 1 point from baseline to any point during 14 days after AXIOS stent placement and GOOS remaining at 1 or more without the need for reintervention due to loss of stent function at 30 days post-index procedure or death, whichever comes first. |
through 14 days after procedure
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Tiempo hasta la reanudación de la ingesta oral después de la colocación del stent.
Periodo de tiempo: Inmediatamente después del procedimiento
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Inmediatamente después del procedimiento
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Hora de iniciar o reanudar la quimioterapia después de la colocación del stent AXIOSTM (cuando corresponda)
Periodo de tiempo: Inmediatamente después del procedimiento
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Inmediatamente después del procedimiento
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Cambio en la puntuación de calidad de vida (cuestionario SF-12) desde el inicio hasta los 30 días, 3 meses, 6 meses y 12 meses
Periodo de tiempo: Hasta la finalización del estudio, un promedio de 1 año.
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Hasta la finalización del estudio, un promedio de 1 año.
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Clinical success over time defined as improvement of GOOS by 1 point from baseline at any time during 14 days after AXIOS stent placement and GOOS remaining at 1 or more. This endpoint will be evaluated at 3 months, 6 months, and 12 months
Periodo de tiempo: Through study completion, an average of 1 year
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A patient undergoing reintervention for GOO is considered a failure of clinical success |
Through study completion, an average of 1 year
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Incidence of Device Deficiencies
Periodo de tiempo: Immediately after the procedure
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Including but not limited to stent migration/misplacement, stent occlusion, leakage at site of stent placement. |
Immediately after the procedure
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Incidence of Reintervention for GOO
Periodo de tiempo: Immediately after the procedure
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defined as need for repeat treatment for persistent or recurrent GOO symptoms |
Immediately after the procedure
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Shayan Irani, MBBS, MD, Virginia Mason Medical Center
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E7152
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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