multicenter, prospective, single arm study will include up to 45 patients, (up to 30 patients per site), aimed at evaluating the performance of the EndoZip System in obese patients with type 2 diabetes and / or hypertension who failed to reduce weight with non-surgical weight-loss methods. Patients will be enrolled in 2 clinical sites in Europe. Patients who meet the eligibility criteria is expected to come the clinic for at least 10 visits.
study will include up to 45 (up to 30 patients per site), ages of 21 -75 of obese patients (BMI 30-40 kg/m²) who failed to reduce weight with non-surgical weight-loss methods. At least 50% of the population included in the study diagnosed with Type 2 diabetes (T2D), and with HbA1c \< 9 at least 6 months prior to study enrollment, excluding Insulin-dependent and / or At least 50% of the population included in the study diagnosed with hypertension, treating with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment. The duration for each participant will be 12 months and will include the following follow up visits and procedures: * Office visits: screening, procedure day, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s) * Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s) * Endoscopy: procedure day and 2 months * Electrocardiogram (ECG) test: Screening and procedure day * FibroScan test: Screening, 6 and 12 months * 24- hours Home Ambulatory Blood Pressure Monitor (ABPM), only for patients diagnosed with hypertension: Screening, 6 and 12 months * Laboratory tests including: (1) Hematology blood tests, (2) Biochemistry blood tests for: sugar Metabolism, liver, proteins, and lipid (3) Urinalysis (Dipstick) tests: Screening, 6 and 12 months. * Physical examination (include at minimum examination of: GI, Cardiopulmonary, Hepatobiliary and extremities systems) - Screening and procedure day. * Vital signs (blood pressure and heart rate - supine, pulse, body temperature, respiratory rate (RR) and SpO2): Screening, procedure day, 1 week, 1, 2, 4, 6, 8, 10 and 12 months * BMI and Waist circumference: Screening, procedure day, 1 week, 1, 2, 4, 6, 8, 10 and 12 months * Meeting with dietitians / lifestyle modifications counseling: at all follow up office and remote visits: * Office visit: Screening, procedure day, 1 week, 1, 2, 4, 6, 8, 10 and 12 months * Remote follows up (phone calls) at months 3,5,7,9, and 11. * IWQOL-Lite: Screening, 2, 6 and 12 months * PHQ-9: Screening * Pregnancy test (only for the relevant population): Procedure day The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
38
The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (up to 5 sutures) 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.
IKEM MC
Prague, Praha 4, Czechia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Percent of total body weight loss (%TBWL) after 12 months.
percent of TBWL from baseline (prior to EndoZip procedure) and 12 month post EndoZip
Time frame: 12 months
Percent of patients with a reduction in %TBWL of at least 10% at 12 months
Percentage of patients with a reduction in %TBWL of at least 10% at 12 months
Time frame: 12 months
safety evaluation- Rate of adverse events
The cumulative incidence of adverse events observed during the procedure and throughout the follow-up period, will be presented in tabular format. A detailed list of all adverse events will be presented. The adverse event rate will be compiled with respect to seriousness, severity, expectedness and relationship to procedure and device.
Time frame: 12 months
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