- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02443753
EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
A Pilot Safety and Tolerability Study of the Use of the EndoBarrier® SANS™ in Over-weight or Obese Type 2 Diabetic Subjects
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
This study will be conducted at a single clinical site in Malaysia. Approximately 16 subjects will be enrolled in two cohorts of 8 subjects. The two cohorts will be implanted one week apart with the implantation of the second cohort triggered by the absence of major technical or clinical issues (i.e. safety, tolerability) observed in the first cohort in the first seven days.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kuala Lumpur, Malasia, 50603
- Universiti Malaya Medical Centre, Jalan universiti
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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:
- Age > 21 years and < 65 years - male or female
- Overweight or obese individuals (BMI ≥ 27 kg/m2 and ≤ 40 kg/m2)
- Diagnosed with Type 2 diabetes and being treated by diet or oral agents (metformin, SU, DPP-4i, or TZD)
- Glycemic state: HbA1c at screening 7.0-10.0%.
- History of failure with non-surgical weight loss methods
- Subjects willing to comply with study requirements
- Subjects who have signed an informed consent form
Exclusion Criteria:
Diabetic subjects requiring injectable treatments (insulin, GLP-1R agonists)
- Subjects requiring anticoagulation therapy
- Subjects with iron deficiency and iron deficiency anemia
- Condition of the gastrointestinal tract, such as ulcers or inflammatory bowel disease
- Treatment represents an unreasonable risk to the subject
- Known history of acute or chronic pancreatitis
- Known history of organ failure (i.e. renal insufficiency, heart failure, fibrotic / cirrhotic liver disease, or pulmonary disease)
- Symptomatic coronary artery disease or pulmonary dysfunction
- Subjects with known symptomatic biliary disease
- Known infection at the time of implant
- Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses
- Pregnant or has the intention of becoming pregnant in the next 6 months
- Unresolved alcohol or drug addiction
- HIV positive subjects
- Subjects with hepatitis B or C
- Currently taking the following medications within 30 days of implant:
systemic corticosteroids, drugs known to affect GI motility, prescription or over the counter weight loss medications such as Sibutramine hydrochloride monohydrate and Orlistat
- Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, and all equivalent antibiotics
- Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement in this clinical trial
- Previous GI surgery that could affect the ability to place the liner or the function of the implant.
- Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- H. pylori positive subjects (Note: patients may be enrolled if they had a prior history and were successfully treated).
- Family or subject history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Unable to tolerate proton pump inhibitors
- Participating in another ongoing investigational clinical trial that is ongoing or within 3 months of the implant date
- Positive stool guaiac at time of screening
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: Device
Subjects who receive the device
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Eligible subjects will be implanted with the EndoBarrier® SANS™ Device for a period of 3 months.
The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis.
The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Safety and Tolerability will be evaluated as the incidence of AEs and SAEs/UADEs.
Periodo de tiempo: 3 months
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Safety will be evaluated as the incidence of AEs and SAEs/UADEs.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Efficacy as measured by Change in Body weight
Periodo de tiempo: 3 months
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Change in Body weight
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3 months
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Efficacy as measured by Percent excess weight loss
Periodo de tiempo: 3 months
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Percent excess weight loss
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3 months
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Efficacy as measured by Change in HbA1c (%)
Periodo de tiempo: 3 months
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Change in HbA1c (%)
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3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Eng Hong Pok, MD, University of Malaya
- Investigador principal: Wah Kheong Chan, MD, University of Malaya
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-1
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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