Clinical trial NCT03472196: NitiNotes' EndoZip System for the Treatment of Obesity
Official title: First in Human Clinical Study to Assess the Safety and Preliminary Performance of NitiNotes' Endoluminal Gastroplasty System (EndoZip) for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Nitinotes Surgical Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm, open label study
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: Inclusion Criteria:

1. Subject, male or female, is age 18 to 60 years of age.
2. Subject must be able to understand and be willing to sign an informed consent form.
3. 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.
4. Subject has a BMI of 30-40 kg/m2
5. Have had no significant weight change (±5% of total body weight) during 6 months prior to enrollment
6. Subject must be fully ambulatory, without chronic reliance on walking aids such as crutches, walkers or a wheelchair.
7. Subject must be of sufficient and stable medical and mental health, as evaluated by the Principal Investigator.
8. Subject must have a primary care physician that will manage the subject for any co-morbid conditions throughout the study.
9. Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination.
10. 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
11. Type II Diabetes patients who are treated with oral glucose lowering agent and are stable are acceptable.

Exclusion Criteria:

1. Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis.
2. Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease.
3. Uncontrolled diabetes or change in diabetes medication and/or dosage in the 3 months prior to enrolment
4. Uncontrolled hypertension
5. Subject with heart failure, NYHA grade 2 and above.
6. Subject has pre-existing respiratory disease, such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
7. 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.
8. Subject has renal and/or hepatic insufficiency/disease (creatinine above 1.5 mg/dL)
9. Subject has thyroid disease, which is not controlled with medication.
10. Subject is diagnosed with ostocorticular pain, pre-neoplastic lesions or coagulation conditions that may prevent him/her from undergoing a surgical procedure.
11. Subject has a history of intestinal strictures or adhesions and/or any condition that could preclude passage of endoluminal instruments.
12. 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.
13. Subject is diagnosed with a coagulation disorder.
14. Subjects undergoing chronic steroid therapy.
15. Subjects undergoing immunosuppressive therapy.
16. Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the procedure as well as during the trial period.
17. Subjects who have known hiatal hernias greater than 5 cm.
18. Subjects who have poorly controlled psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
19. Subject has active Crohn's disease or Colitis.
20. Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
21. Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within 6 months prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study and their participation may interfere with the current study.
22. Subject has any condition that, at the discretion of the investigator, would preclude participation in the study.
23. Unstable diabetes patients who are treated with insulin.

Primary outcomes:
measure: Primary - Serious Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy - Suture Durability
timeFrame: 6 months
measure: Efficacy - % Excess Weight Loss (EWL)
timeFrame: 6 months
Other outcomes:
measure: Exploratory - Waist Circumference
timeFrame: 6 months
measure: Exploratory - Quality Of Life Questionnaire
timeFrame: 6 months
measure: Exploratory - % Total Body Weight Loss (TBWL)
timeFrame: 6 months
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
Study officials:
References:
citation: 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.