STELLA® Endogastric Balloon System. Evaluation of Safety and Introduction System at 7 Months.

Prior treatment

• Patients who are participating or have participated in another clinical trial within the previous 30 days.
• Patients who have previously had an endogastric balloon placed, even if it has been successful, and request the prescription of a second balloon.
• Patients undergoing pharmacological treatment with anticoagulants, antiplatelet agents and/or NSAIDs.
• Patients with previous surgery, bariatric or gastrointestinal surgery.
• Previous esophageal or gastric surgery.

Other illness

• Systemic diseases that prevent correct monitoring.
• Patients with psychological or psychiatric disorders that, in the opinion of the psychologist, contraindicate their inclusion.
• Patients with active esophagogastric pathology: Inflammatory: severe esophagitis (Los Angeles C-D), eosinophilic esophagitis, gastric and/or duodenal ulcer, Crohn's disease. Vascular: potentially bleeding lesions (varicose veins, angiomas, angiectasias). Neoplasia.
• Allergy to any of the implantable components.

Other

• Patients who, in the opinion of the principal investigator or any of the specialists of the multicenter team, are not able to follow the instructions or to comply well with the assigned dietary treatment.
• Patients who do not give written informed consent to participate in the study.
• Pregnancy and breastfeeding.
• Unfavourable social-familial environment.
• Patients with large hiatal hernia.
• Anatomical alterations: digestive stenosis or occlusion.
• Hormonal, endocrine or genetic causes of obesity.

• Subjects who are overweight or obese, men and women, between 18 and 65 years of age, who have failed with previous diets and who require a physical aid that increases the sensation of satiety to reduce the amount of intake and thus promote weight loss.
• Subjects with overweight grade II (BMI between 27.00-29.99 kg/m²) and obesity grade I (BMI between 30.00-34.99 kg/m²).
• Subjects with grade II obesity (BMI between 35.00-39.99 kg/m²) provided they do not have more than 3 major comorbidities associated with obesity.
• Morbidly obese subjects (BMI ≥40 kg/m²) requiring weight loss by endogastric balloon prior to bariatric surgery.
• Subjects who freely give written consent.
• The Stella balloon is especially indicated for patients with abnormal structures of the esophagus, oropharynx or with reduced lumen size, diverticula, or other processes as long as they are benign and do not impede the passage of the endoscope.