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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tulip capsule | Experimental | swallowing Tulip capsule for up to 29 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulip capsule | Device | swallowing Tulip capsule for up to 29 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 days |
| Satisfying evacuation of the balloon from the stomach after oral intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sigal Fishman, Dr. | Contact | 972-3-6974469 | sigalf@tlvmc.gov.il | |
| Tair Lapidot, Dr. | Contact | 972-72-2505995 | 105 | tair@tulipmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Sigal Fishman, Dr. | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center , Gastroenterology - Institute | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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Number of subjects showing satisfying evacuation of the balloon from the stomach after oral intake by means of a gastroscopic examination |
| 36 days |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |