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

NCT05623163 | Completed

• 1 other identifier: CL00010
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• Percent of total body weight loss (%TBWL) after 12 months.

  percent of TBWL from baseline (prior to EndoZip procedure) and 12 month post EndoZip

  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

  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.

  12 months

Study Arms (1)

EndoZip System

EXPERIMENTAL

The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (up to 5) 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.

Device: EndoZip System

Interventions

EndoZip System DEVICE

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.

EndoZip System

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-75
• BMI ≥ 27 and ≤40 kg/m².
• Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
• Patients with history of failure with non-surgical weight-loss methods.
• Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, completing IWQOL questionnaire and completing the medically supervised diet and behavior modification program.
• Ability to give informed consent.
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control 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.
• 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.

You may not qualify if:

• Prior surgery of any kind on the gastrointestinal tract (except uncomplicated cholecystectomy or appendectomy).
• Patients with history of small bowel or colonic obstruction, and/or adhesive peritonitis and/or abdominal adhesions.
• Patients with any inflammatory disease
• Patients with history of cancer in the gastrointestinal tract.
• Potential upper gastrointestinal bleeding conditions such as a history of angioectasias.
• A known gastric mass or gastric polyps \> 1 cm in size.
• Patients with TG \>500 or LDL \>190
• Patients with BP \>180 / 110
• A known hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy.
• A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
• Patient with motility disorders of the GI tract or intractable constipation
• Patients with known coagulation disorder (INR \>1.5) or on anticoagulation therapy.
• Type 1 diabetes or Type 2 diabetes with a HgbA1c \>9 and/or injectable medications or likely requiring insulin treatment in the following 12 months.
• Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Patients with chronic abdominal pain

Sponsors & Collaborators

• Nitinotes Surgical Ltd.: lead

Study Sites (2)

IKEM MC

Prague, Praha 4, 140 59, Czechia

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ravit Peled

  NiTiNotes Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 21, 2022
• Study Start: February 15, 2023
• Primary Completion: November 15, 2024
• Study Completion: December 30, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); IT (1)