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METHOD (Minimally Invasive, Endoscopically-delivered, Tolerable by Human Individuals, Non-morbid Obesity Device) Study

Sensate LLC · 2008
ClinicalTrials.gov · Datasets · License: Public Domain · 2008
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obesity
This will be an open label, single-center, feasibility study comprised of two sequential cohorts( cohort 1: 2 participants; cohort 2: 8 participants). This study will be conducted in generally healthy participants aged 25 to 55 years with non-morbid obesity and a pre-screening body mass index between 35 and 40. Participants will undergo screening to determine their health status and their eligibility to participate in the study. Eligible patients will undergo an endoscopic device delivery procedure during which the device will be anchored in the inner stomach wall at the distal anterior antrum. Physical examination and/or endoscopic safety evaluations will be conducted on day 14 and 28. The device and its anchor will be completely removed endoscopically after 8 weeks. The participants will be followed-up for safety evaluation for an additional period of 2 weeks.
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