NitiNotes' EndoZip System for the Treatment of Obesity

NCT03472196 | Completed

• 1 other identifier: CLP-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Primary - Serious Adverse Events

  Incidence of device related SAEs within 6 months post procedure

  6 months

Secondary Outcomes (2)

• Efficacy - Suture Durability

  6 months

• Efficacy - % Excess Weight Loss (EWL)

  6 months

Other Outcomes (3)

• Exploratory - Waist Circumference

  6 months

• Exploratory - Quality Of Life Questionnaire

  6 months

• Exploratory - % Total Body Weight Loss (TBWL)

  6 months

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: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject, male or female, is age 18 to 60 years of age.
• Subject must be able to understand and be willing to sign an informed consent form.
• Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
• Subject has a BMI of 30-40 kg/m2
• Have had no significant weight change (±5% of total body weight) during 6 months prior to enrollment
• Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
• Subject must be of sufficient and stable medical and mental health, as evaluated by the Principal Investigator.
• Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
• Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination.
• Subject agrees not to have any additional weight loss interventional procedures, such as mammoplasty or abdominal lipoplasty or liposuction, or take any over the counter or prescription weight loss medication for the entire study participation duration
• Type II Diabetes patients who are treated with oral glucose lowering agent and are stable are acceptable.

You may not qualify if:

• Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
• Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
• Uncontrolled diabetes or change in diabetes medication and/or dosage in the 3 months prior to enrolment
• Uncontrolled hypertension
• Subject with heart failure, NYHA grade 2 and above.
• Subject has pre-existing respiratory disease, such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
• Subject has significant esophageal disease including Zenker's diverticulum, severe gastro-esophageal reflux disease (GERD), stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility, which is not controlled with medication.
• Subject has renal and/or hepatic insufficiency/disease (creatinine above 1.5 mg/dL)
• Subject has thyroid disease, which is not controlled with medication.
• Subject is diagnosed with ostocorticular pain, pre-neoplastic lesions or coagulation conditions that may prevent him/her from undergoing a surgical procedure.
• Subject has a history of intestinal strictures or adhesions and/or any condition that could preclude passage of endoluminal instruments.
• Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to device use), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
• Subject is diagnosed with a coagulation disorder.
• Subjects undergoing chronic steroid therapy.
• Subjects undergoing immunosuppressive therapy.

Sponsors & Collaborators

• Nitinotes Surgical Ltd.: lead

Study Sites (1)

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Location

Related Publications (1)

• 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.

  PMID: 31898051 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

Study Design

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

Model Details: Open label, single arm, open label study

Study Record Dates

• First Submitted: March 4, 2018
• First Posted: March 21, 2018
• Study Start: March 21, 2018
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2019
• Last Updated: February 23, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)