ObesityNCT04773795

Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods

A study testing EndoZip System in people with Obesity, run by Nitinotes Surgical Ltd. at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
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: 48 participants
Where: 1 siteSpain
Study dates: 30 Jun 2021to 3 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 21-70
BMI ≥ 30 and ≤40 kg/m².
Willingness to comply with the substantial behavioral modifications program 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.
Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits.
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.

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.

Show all 31Show fewer

Patients with TG >500 or LDL >190
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 >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
Patients with chronic abdominal pain
Patients with hepatic insufficiency or cirrhosis
Patients that used an intragastric device for weight loss within 2 years prior to this study.
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.
Patients with history or current abuse of drugs or alcohol
Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
egg, milk, or wheat allergy (unable to go through the GEBT)
Patients who are pregnant or breast-feeding.
Patients who are taking medications that cause weight loss
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
Patients taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
Patients who are taking corticosteroids, immunosuppressants, and narcotics
Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
Pre-existing respiratory disease such as chronic obstructive pulmonary disease (severe COPD), pneumonia or cancer.
Diagnosis of autoimmune connective tissue disorder (e.g. lupus, HIV, erythematous, scleroderma) or immunocompromised.
Specific diagnosed genetic disorder such as Prader Willi syndrome (motility disorder)
Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Hospital Universitario HM Sanchinarro
Madrid, 28050

Other trials in Spain

About this study

Read the 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).

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 (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.

Study groups in NCT04773795
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 (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. Receives: Device: EndoZip System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 month
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.
Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 20213 Jul 2023

First posted26 Feb 2021
Study start30 Jun 2021
Primary completion10 Feb 2023
Study completion3 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04773795
Sponsor's protocol ID: CL00003
Status last verified: Aug 2025
First submitted: 21 Feb 2021
Last updated: 13 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Boskoski I, Lopez-Nava G, Ravishankar A, Bove V, Matteo MV, De Siena M, Pontecorvi V, Giannetti G, Iaconelli A, Spada C, Shamah SE. Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video). Gastrointest Endosc. 2025 Apr;101(4):818-827. doi: 10.1016/j.gie.2024.09.026. Epub 2024 Sep 21.
PubMed 39307402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of EndoZip System in Obese Patients Who Failed to Reduce Weight With Non-surgical Weight-loss Methods
ClinicalTrials.gov ID: NCT04773795
Acronym / sponsor ID: CL00003
Conditions: Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Nitinotes Surgical Ltd.Industry (pharma, biotech, devices)
Study start: 30 Jun 2021 (actual)
Primary completion: 10 Feb 2023 (actual)
Study completion: 3 Jul 2023 (actual)
First posted: 26 Feb 2021 (actual)
Results: Posted 13 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

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 (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.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 21-70
BMI ≥ 30 and ≤40 kg/m².
Willingness to comply with the substantial behavioral modifications program 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 (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.	Device	EndoZip System

Primary outcome

Change in Body Total Body Weight Loss (kg) From Baseline to12 Months
Time frame: 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.
Time frame: 12 month
Percentage of patients with a reduction in %TBWL of at least 5% from baseline to 12 months.

Results and safety

Results posted to the registry on 13 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EndoZip System	48	45

Primary outcome: Change in Body Total Body Weight Loss (kg) From Baseline to12 Months

Time frame: 12 month. Mean (Standard Error). Unit: kg

Measure	EndoZip System n = 45
Value	13.2 (1.5)

Primary outcome: Percentage of Patients With a Reduction in %TBWL of at Least 5% From Baseline to 12 Months.

Time frame: 12 month. Count of participants. Unit: Participants

Measure	EndoZip System n = 45
Value	34

Adverse events

Time frame: 1 year after the EndoZip procedure. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EndoZip System	2 of 45 (4.4%)	2 of 45 (4.4%)	3 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39307402Boskoski I, Lopez-Nava G, Ravishankar A, Bove V, Matteo MV, De Siena M, Pontecorvi V, Giannetti G, Iaconelli A, Spada C, Shamah SE. Automatic endoscopic gastroplasty for the treatment of obesity: results from a prospective multicenter study (with video). Gastrointest Endosc. 2025 Apr;101(4):818-827. doi: 10.1016/j.gie.2024.09.026. Epub 2024 Sep 21.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
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Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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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

1 site in 1 country: 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 1 site in Spain.

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 8 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Body Total Body Weight Loss (kg) From Baseline to12 Months (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04773795, which also lists 1 linked publication.

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 13 Aug 2025.