Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure — CL00010  

Obesity Clinical Trial

Official title: Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT05623163
• Study type: Interventional
• Source: Nitinotes Surgical Ltd.
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2023
• Completion date: December 30, 2024