First in Human Clinical Study to Assess the Safety and Preliminary Performance of NitiNotes' Endoluminal Gastroplasty System (EndoZip) for the Treatment of Obesity

Nitinotes Surgical Ltd.1 site in 1 country14 target enrollmentMarch 21, 2018

ConditionsObesity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obesity
Sponsor: Nitinotes Surgical Ltd.
Enrollment: 14
Locations: 1
Primary Endpoint: Primary - Serious Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 21, 2018

End Date

May 8, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nitinotes Surgical Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.