Obesity Clinical Trial
Official title:
Multicenter, Randomized, Controlled and Double-blind Study of Efficacy and Safety of Endoscopic Gastric Tubulization in Patients With Non-alcoholic Steatohepatitis (NASH-APOLLO).
Nonalcoholic steatohepatitis is a growing public health problem affecting over 5% of the
population. These patients are at increased risk of cardiovascular and liver-related death
and have higher rates of malignancy.
The currently standard of care is weight loss and physical exercise, with histological and
analytical improvement in patients achieving a 5-10% reduction in body weight. However, less
than 25% of the subjects achieve this goal. In obese patients , restrictive surgical
treatments and gastric bypass have been successful in improving the metabolic syndrome,
insulin resistance and liver histology.
Currently, less invasive and less costly endoscopic techniques are being developed. These
techniques also achieve a gastric restriction with similar results than bariatric surgery.
One of these is the OverStitch® system (Apollo Endosurgery, Austin, TX, USA). Our aim is to
evaluate the efficacy and safety of this method in the improvement of liver histology in
obese patients with nonalcoholic steatohepatitis.
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