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This is first-in-man safety and performance feasibility study, aimed to provide initial clinical assessment of safety and effectiveness of the EndoZip in the treatment of obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoZip System | Experimental | The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoZip System | Device | The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within. Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary - Serious Adverse Events | Incidence of device related SAEs within 6 months post procedure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Suture Durability | Success rate at 6 months after procedure by assessment of the stitches durability / gastroplasty shape in the stomach, to be determined by the investigator using endoscopy and/or Barium X-ray (per physician discretion) at pre-determined intervals. | 6 months |
| Efficacy - % Excess Weight Loss (EWL) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory - Waist Circumference | Change in waist circumference from baseline to 6 months post procedure. | 6 months |
| Exploratory - Quality Of Life Questionnaire | Subject change in Patient Assessment of Upper Gastrointestinal Disorders Quality of Life questionnaire (PAGI-QoL) total score from baseline to 6 months post procedure. Total score ranges from 0 (best score) to 45 (worst score). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31898051 | Derived | Lopez-Nava G, Asokkumar R, Rull A, Fernandez-Corbelle, Bautista I, Dayyeh BA. Safety and Feasibility of a Novel Endoscopic Suturing Device (EndoZip TM) for Treatment of Obesity: First-in-Human Study. Obes Surg. 2020 May;30(5):1696-1703. doi: 10.1007/s11695-019-04370-w. |
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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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Open label, single arm, open label study
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|
%EWL after 6 months from baseline |
| 6 months |
| 6 months |
| Exploratory - % Total Body Weight Loss (TBWL) | %TBWL after 6 months from baseline | 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |