¿En qué consiste este ensayo clínico?
Este ensayo clínico tiene como objetivo investigar si este tratamiento experimental que implica la ablación de hasta el 70% de la mucosa gástrica daría como resultado una pérdida de peso.
¿Cómo participar en este ensayo clínico?
Criterios clave para tienen:
Criterios clave no tener:
- No debe tomar los siguientes medicamentos:
- Exogenous insulin or any types of insulin
- Glucose lowering drugs, excluding sulfonylurea (SU), biguanides sodium dependent glucose co-transporter 2 (SGLT-2) inhibitors
- Anti-coagulation therapy
- Obligate use of anti-inflammatory drugs that cannot be suspended for a minimum of 4 weeks after the procedure
- Systemic glucocorticoids
- Drugs known to affect GI motility (ie. Metoclopramide)
- Weight loss medications (ie. Meridia, Xenical, Saxenda, Januvia, Duromine or over the counter-weight loss medications)
- No debe tener las siguientes afecciones:
- Estar embarazada o en periodo de lactancia o tener intención de quedarse embarazada durante el estudio.
- Experience chronic upper abdominal pain, nausea, vomiting, dyspepsia, post-prandial fullness or pain
- Autoimmune disease, excluding autoimmune thyroid disease which is adequately replaced
- Diabetic gastroparesis
- History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
- Known active hepatitis or active liver disease other than Non-Alcoholic Fatty Liver Disease or Non-Alcoholic Steatohepatitis
- Acute gastrointestinal illness in the previous 7 days.
- Known history of irritable bowel syndrome
- Active pylori infección
- Significant cardiovascular disease
- Known immunocompromised status
- Active systemic infection
- Known active malignancy within the last 5 years
- Known multiple endocrine neoplasia syndrome type 1
- Active illicit substance abuse or alcoholism
- Current smoker or smoking history in the last 3 months
- Estar embarazada o en periodo de lactancia o tener intención de quedarse embarazada durante el estudio.
- You should not have undergone upper GI surgery, other endoscopic bariatric procedures or conditions, intra-gastric balloon or gastric implants
¿Cuánto duraría la participación en el ensayo?
From the time of study enrollment, your participation would last up to 15 months.
¿Dónde se realiza este ensayo clínico?
The procedure will be carried out at True You Weight Loss (Raleigh Endoscopy Centre, 2001 Weston Parkway, Cary, NC 27513)
¿Me indemnizarán?
Participants will be compensated for their time, effort, and inconvenience. This includes up to $2,800 in compensation and incentive payments. Participants will also receive the procedure at no-cost.
Puede obtenerse más información sobre el estudio en ClinicalTrials.gov.
Estado del estudio: inscripción completa; resultados pendientes
