Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods

NCT04773795 | Completed Results

• 1 other identifier: CL00003
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, prospective, single-arm, open-label, controlled clinical trial aimed to evaluate the safety and effectiveness of the EndoZip system procedure, coupled with lifestyle modifications, for weight reduction in obese patients with BMI of 30-40 kg/m2.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Change in Body Total Body Weight Loss (kg) From Baseline to12 Months

  Change in body total body weight loss (kg) from baseline to 12 months post EndoZip procedure

  12 month

• Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months.

  Percentage of patients with a reduction in %TBWL of at least 5% from baseline to 12 months.

  12 month

Study Arms (1)

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.

Device: EndoZip System

Interventions

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.

EndoZip System

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-70
• BMI ≥ 30 and ≤40 kg/m².
• Willingness to comply with the substantial behavioral modifications program 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.
• Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.
• 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.

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
• 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 \>8 in 6 weeks prior the procedure or use of any medication for diabetes other than metformin. Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
• Patients with chronic abdominal pain
• Patients with hepatic insufficiency or cirrhosis
• Patients that used an intragastric device for weight loss within 2 years prior to this study.

Sponsors & Collaborators

• Nitinotes Surgical Ltd.: lead

Study Sites (1)

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Related Publications (1)

• Boskoski I, Lopez-Nava G, Ravishankar A, Bove V, Matteo MV, De Siena M, Pontecorvi V, Giannetti G, Iaconelli A, Spada C, Shamah SE. Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video). Gastrointest Endosc. 2025 Apr;101(4):818-827. doi: 10.1016/j.gie.2024.09.026. Epub 2024 Sep 21.

  PMID: 39307402 DERIVED

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

Results Point of Contact

• Title: Ravit Peled- Director of clinical operations
• Organization: Nitinotes Ltd.

ravit@nitinotesurgical.com

0526145354

Study Officials

• Ravit Peled

  NiTiNotes Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: February 21, 2021
• First Posted: February 26, 2021
• Study Start: June 30, 2021
• Primary Completion: February 10, 2023
• Study Completion: July 3, 2023
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)