The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon, packed in a swallow-able capsule, in healthy subjects with 30 \< BMI≤ 35.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
swallowing Tulip capsule for up to 29 days
Tel Aviv Sourasky Medical Center , Gastroenterology - Institute
Tel Aviv, Israel
Number of subjects with device related serious adverse events
Safety will be assessed descriptively by summarizing device related SAEs, gastroscopic examination, daily diary, vital sign measurements, physical examination and abdomen circumference.
Time frame: 36 days
Patient assessment of capsule tolerability
Comfort and tolerability will be assessed by the patient and will be recorded in a daily diary. Tolerability evaluation will include: assessment of swallow ability, gastrointestinal comfort, defecation effort, appetite.
Time frame: 36 days
Satisfying evacuation of the balloon from the stomach after oral intake
Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination
Time frame: 36 days
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