Obesity
Conditions
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.
Detailed description
study will include up to 45 (10-20 patients per site), ages of 21 -70 of obese patients who failed to reduce weight with non-surgical weight-loss methods. The duration for each participant will be 12 months and will include the following follow up visits and procedures: * Office visits: screening, 1 week, and 1, 2, 4, 6, 8, 10, and 12 month(s) * Remote follow up (by Phone): 3, 5, 7, 9, and 11 month(s) * Endoscopy procedure: baseline, 2 and 6 months post EndoZip procedure * Motility evaluation by Gastric Emptying Breath Test (GEBT): baseline, 6 months * Physical examination, vital signs, waist circumference and BMI: baseline, 1 week, 1, 2, 4, 6, 8, 10 and 12 months * Blood tests: baseline,2, 6 and 12 months * IWQOL-Lite: baseline, 2, 6 and 12 months * Psychological health questionnaire-9 (PHQ-9) :baseline * Sleep Apnea (only for the relevant population): baseline 2, 6 and 12 months The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).
Interventions
DEVICEEndoZip System
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.
Sponsors
Nitinotes Surgical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 21-70 2. BMI ≥ 30 and ≤40 kg/m². 3. Willingness to comply with the substantial behavioral modifications program as required by the procedure. 4. Patients with history of failure with non-surgical weight-loss methods. 5. 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. 6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits. 7. Ability to give informed consent. 8. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
Exclusion criteria
1. Prior surgery of any kind on the gastrointestinal tract (except uncomplicated cholecystectomy or appendectomy). 2. Patients with history of small bowel or colonic obstruction, and/or adhesive peritonitis and/or abdominal adhesions. 3. Patients with any inflammatory disease 4. Patients with history of cancer in the gastrointestinal tract. 5. Potential upper gastrointestinal bleeding conditions such as a history of angioectasias. 6. A known gastric mass or gastric polyps \> 1 cm in size. 7. Patients with TG \>500 or LDL \>190 8. 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. 9. A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope. 10. Patient with motility disorders of the GI tract or intractable constipation 11. Patients with known coagulation disorder (INR \>1.5) or on anticoagulation therapy. 12. 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 13. Patients with chronic abdominal pain 14. Patients with hepatic insufficiency or cirrhosis 15. Patients that used an intragastric device for weight loss within 2 years prior to this study. 16. Patients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher. 17. Patients receiving daily prescribed treatment with high dose aspirin (\> 100mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants. 18. Patients with history or current abuse of drugs or alcohol 19. Patients who are unable or unwilling to take prescribed proton pump inhibitor medication 20. egg, milk, or wheat allergy (unable to go through the GEBT) 21. Patients who are pregnant or breast-feeding. 22. Patients who are taking medications that cause weight loss 23. Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 12 months, poorly-controlled hypertension, required use of NSAIDs 24. Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications 25. Patients who are taking corticosteroids, immunosuppressants, and narcotics 26. Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease. 27. Pre-existing respiratory disease such as chronic obstructive pulmonary disease (severe COPD), pneumonia or cancer. 28. Diagnosis of autoimmune connective tissue disorder (e.g. lupus, HIV, erythematous, scleroderma) or immunocompromised. 29. Specific diagnosed genetic disorder such as Prader Willi syndrome (motility disorder) 30. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating 31. Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Total Body Weight Loss (kg) From Baseline to12 Months | 12 month | Change in body total body weight loss (kg) from baseline to 12 months post EndoZip procedure |
| Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months. | 12 month | Percentage of patients with a reduction in %TBWL of at least 5% from baseline to 12 months. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EndoZip System 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: 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. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | EndoZip System | — |
|---|---|---|
| Age, Continuous | 44.13 years STANDARD_DEVIATION 8.76 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 45 |
| other Total, other adverse events | 2 / 45 |
| serious Total, serious adverse events | 2 / 45 |
Outcome results
Primary
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
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EndoZip System | Change in Body Total Body Weight Loss (kg) From Baseline to12 Months | 13.2 kg | Standard Error 1.5 |
Primary
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.
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoZip System | Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months. | 34 Participants |