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Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure (CL00010)

Primary Purpose

Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EndoZip System
Sponsored by
Nitinotes Surgical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 21-75 BMI ≥ 27 and ≤40 kg/m². Willingness to comply with the substantial behavioral modifications and dietary restrictions 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. 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. At least 50% of the population included in the study diagnosed with Type 2 diabetes (T2D), and with HbA1c < 9 at least 6 months prior to study enrollment, excluding Insulin-dependent. At least 50% of the population included in the study diagnosed with hypertension, treating with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment. Exclusion Criteria: 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 Patients with BP >180 / 110 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 >9 and/or injectable medications or likely requiring insulin treatment in the following 12 months. 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 (CAB>290 Db/m or Fibrosis score >10 kPa) Patients with viral and / or autoimmune hepatitis Presence of any other form of chronic liver disease Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid) Any contraindication to liver biopsy Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose of ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline Patients that used an intragastric device for weight loss Patients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher. Patients receiving daily prescribed treatment with high dose aspirin (> 100mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants or on low dose aspirin and cannot come of medication for a total of 10 days peri procedure. Patients with history or current abuse of drugs or alcohol Patients who are unable or unwilling to take prescribed Proton Pump Inhibitor (PPI) medication Patients who are pregnant or breast-feeding. Patients who are taking medications that cause weight loss within the last 6 months 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 and / or poorly-controlled hypertension Patients are currently on medications that are known to affect gastric emptying, such as anti-seizure or anti-arrhythmic medications and / or poorly-controlled Glycemia Patients who are taking corticosteroids, immunosuppressants, or narcotics and cannot come of medication for the study period.

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EndoZip System

Arm Description

The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (up to 5) 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.

Outcomes

Primary Outcome Measures

Percent of total body weight loss (%TBWL) after 12 months.
percent of TBWL from baseline (prior to EndoZip procedure) and 12 month post EndoZip
Percent of patients with a reduction in %TBWL of at least 10% at 12 months
Percentage of patients with a reduction in %TBWL of at least 10% at 12 months
safety evaluation- Rate of adverse events
The cumulative incidence of adverse events observed during the procedure and throughout the follow-up period, will be presented in tabular format. A detailed list of all adverse events will be presented. The adverse event rate will be compiled with respect to seriousness, severity, expectedness and relationship to procedure and device.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2022
Last Updated
November 12, 2022
Sponsor
Nitinotes Surgical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05623163
Brief Title
Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure
Acronym
CL00010
Official Title
Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nitinotes Surgical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
multicenter, prospective, single arm study will include up to 45 patients, (up to 30 patients per site), aimed at evaluating the performance of the EndoZip System in obese patients with type 2 diabetes and / or hypertension who failed to reduce weight with non-surgical weight-loss methods. Patients will be enrolled in 2 clinical sites in Europe. Patients who meet the eligibility criteria is expected to come the clinic for at least 10 visits.
Detailed Description
study will include up to 45 (up to 30 patients per site), ages of 21 -75 of obese patients (BMI 30-40 kg/m²) who failed to reduce weight with non-surgical weight-loss methods. At least 50% of the population included in the study diagnosed with Type 2 diabetes (T2D), and with HbA1c < 9 at least 6 months prior to study enrollment, excluding Insulin-dependent and / or At least 50% of the population included in the study diagnosed with hypertension, treating with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment. The duration for each participant will be 12 months and will include the following follow up visits and procedures: Office visits: screening, procedure day, 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 day and 2 months Electrocardiogram (ECG) test: Screening and procedure day FibroScan test: Screening, 6 and 12 months 24- hours Home Ambulatory Blood Pressure Monitor (ABPM), only for patients diagnosed with hypertension: Screening, 6 and 12 months Laboratory tests including: (1) Hematology blood tests, (2) Biochemistry blood tests for: sugar Metabolism, liver, proteins, and lipid (3) Urinalysis (Dipstick) tests: Screening, 6 and 12 months. Physical examination (include at minimum examination of: GI, Cardiopulmonary, Hepatobiliary and extremities systems) - Screening and procedure day. Vital signs (blood pressure and heart rate - supine, pulse, body temperature, respiratory rate (RR) and SpO2): Screening, procedure day, 1 week, 1, 2, 4, 6, 8, 10 and 12 months BMI and Waist circumference: Screening, procedure day, 1 week, 1, 2, 4, 6, 8, 10 and 12 months Meeting with dietitians / lifestyle modifications counseling: at all follow up office and remote visits: Office visit: Screening, procedure day, 1 week, 1, 2, 4, 6, 8, 10 and 12 months Remote follows up (phone calls) at months 3,5,7,9, and 11. IWQOL-Lite: Screening, 2, 6 and 12 months PHQ-9: Screening Pregnancy test (only for the relevant population): Procedure day The patient will required to follow a specific diet and to have a physical activity during the study period ( 12 month).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EndoZip System
Arm Type
Experimental
Arm Description
The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (up to 5) 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.
Intervention Type
Device
Intervention Name(s)
EndoZip System
Intervention Description
The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (up to 5 sutures) 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.
Primary Outcome Measure Information:
Title
Percent of total body weight loss (%TBWL) after 12 months.
Description
percent of TBWL from baseline (prior to EndoZip procedure) and 12 month post EndoZip
Time Frame
12 months
Title
Percent of patients with a reduction in %TBWL of at least 10% at 12 months
Description
Percentage of patients with a reduction in %TBWL of at least 10% at 12 months
Time Frame
12 months
Title
safety evaluation- Rate of adverse events
Description
The cumulative incidence of adverse events observed during the procedure and throughout the follow-up period, will be presented in tabular format. A detailed list of all adverse events will be presented. The adverse event rate will be compiled with respect to seriousness, severity, expectedness and relationship to procedure and device.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 21-75 BMI ≥ 27 and ≤40 kg/m². Willingness to comply with the substantial behavioral modifications and dietary restrictions 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. 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. At least 50% of the population included in the study diagnosed with Type 2 diabetes (T2D), and with HbA1c < 9 at least 6 months prior to study enrollment, excluding Insulin-dependent. At least 50% of the population included in the study diagnosed with hypertension, treating with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment. Exclusion Criteria: 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 Patients with BP >180 / 110 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 >9 and/or injectable medications or likely requiring insulin treatment in the following 12 months. 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 (CAB>290 Db/m or Fibrosis score >10 kPa) Patients with viral and / or autoimmune hepatitis Presence of any other form of chronic liver disease Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid) Any contraindication to liver biopsy Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose of ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline Patients that used an intragastric device for weight loss Patients with psychological health questionnaire-9 (PHQ-9) score of 10 or higher. Patients receiving daily prescribed treatment with high dose aspirin (> 100mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants or on low dose aspirin and cannot come of medication for a total of 10 days peri procedure. Patients with history or current abuse of drugs or alcohol Patients who are unable or unwilling to take prescribed Proton Pump Inhibitor (PPI) medication Patients who are pregnant or breast-feeding. Patients who are taking medications that cause weight loss within the last 6 months 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 and / or poorly-controlled hypertension Patients are currently on medications that are known to affect gastric emptying, such as anti-seizure or anti-arrhythmic medications and / or poorly-controlled Glycemia Patients who are taking corticosteroids, immunosuppressants, or narcotics and cannot come of medication for the study period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ravit Peled
Phone
+972526145354
Email
ravit@nitinotesurgical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hagit Eprath
Phone
+972523144045
Email
hagit@nitinotesurgical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravit Peled
Organizational Affiliation
NiTiNotes Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivo Boškoski, MD
Phone
39 0630155556
Email
vo.boskoski@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Carolina Gualtieri
Phone
39 06 3015 6580
Email
carolina.gualtieri@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Ivo Boškoski, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure

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