Study design to demonstrate the safety and performance of the Epitomee Device
Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.
Assaf Harofeh Medical Center
Ẕerifin, Israel
Safety evaluation of the Device administration.
Normal Gastroscopic examination as assessed by an independent safety committee.
Time frame: Baseline, 12 weeks
the change in subjects' weight presented as percent total body loss (%TBL)
Subjects loss of weight described as %TBL
Time frame: Baseline, 12 weeks
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