Primary Obesity Surgery Endoluminal 2.0, or POSE 2.0, (USGI Medical, San Clemente, CA) creates full-thickness plications of gastric tissue endoscopically to shorten the stomach and narrow its aperture for weight loss in patients with obesity. Adults with obesity and non-alcoholic NAFLD were allocated based on preference and motivation to undergo the POSE 2.0 procedure with lifestyle modification or lifestyle modification alone to study the impact of the POSE2.0 procedures on NAFLD parameters and metabolic profile. Co-primary endpoints included improvement in controlled attenuation parameter (CAP) and resolution of hepatic steatosis at 12 months. Secondary endpoints included total body weight loss (TBWL), change in serum measures of hepatic steatosis and insulin resistance, and device safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The POSE 2.0 involves full-thickness plications by suture anchor pairs that shorten and tabularize the stomach along its greater curvature. The POSE 2.0 procedure was carried out using the Incisionless Operating Platform (USGI Medical, San Clemente, CA)
The intervention focuses on caloric restriction diet, physical activity, and behavioral modification targeted toward weight loss and administered by a health care professional months for the 12 months duration of the study.
Obaidulla Hospital, Emirates Health Services, Ministry of Health, United Arab Emirates
Ras al-Khaimah, United Arab Emirates
Change in controlled attenuation parameter (CAP)
Measured by Fibroscan XL
Time frame: 12 months
Change in liver stiffness
Measured by Fibroscan XL
Time frame: 12 months
Percent resolution of hepatic steatosis at 12 months
Measured by fibroscan XL
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.