ObesityCL00010NCT05623163
Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure
A study testing EndoZip System in people with Obesity, run by Nitinotes Surgical Ltd. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- EndoZip System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Feb 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
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.
Read the 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).
- Conditions
- Obesity
- Being tested
- EndoZip System
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoZip SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EndoZip System | Experimental | 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. Receives: Device: EndoZip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of total body weight loss (%TBWL) after 12 months.
percent of TBWL from baseline (prior to EndoZip procedure) and 12 month post EndoZip
Measured: 12 months
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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start15 Feb 2023
- Primary completion15 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitinotes Surgical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravit Peled, Study director, NiTiNotes Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623163
- Sponsor's protocol ID
- CL00010
- Acronym
- CL00010
- Status last verified
- Jul 2025
- First submitted
- 6 Nov 2022
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Health Improvement in Obese Patients With Obesity-related Comorbidities Followed by EndoZip Procedure
- ClinicalTrials.gov ID
- NCT05623163
- Acronym / sponsor ID
- CL00010 / CL00010
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Nitinotes Surgical Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoZip System | Experimental | Device: EndoZip SystemThe 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoZip SystemThe 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. | Device | EndoZip System |
Primary outcome
Percent of total body weight loss (%TBWL) after 12 months.
Time frame: 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
Time frame: 12 months
Percentage of patients with a reduction in %TBWL of at least 10% at 12 months
safety evaluation- Rate of adverse events
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravit Peled study director
NiTiNotes Ltd
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoZip System in people with Obesity, run by Nitinotes Surgical Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of total body weight loss (%TBWL) after 12 months. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.