ObesityESGNCT07090005
Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
A study testing EndoZip System and OverStitch Endoscopic Suturing System (ESG) in people with Obesity and Overweight, run by Nitinotes Surgical Ltd. at 5 sites in 2 countries.
Trial summary
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- EndoZip System and OverStitch Endoscopic Suturing System (ESG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 14 Nov 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-65
- BMI ≥ 30 and ≤50 kg/m².
- Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
- 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.
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- 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.
- *** There will be a quota for at least a) 46 patients with hypertension treated with 2 or more antihypertensive medications and are well control at least 6 months prior to study enrollment , b) 46 patients with type II diabetes mellitus on oral agents only with HgbA1c ≤ 9 at least 6 months prior to study enrollment, excluding Insulin-dependent. Thus the cohort of 184 patients will be stratified into four groups (Obesity, Obesity \& HTN, Obesity \& DM, obesity \&HTN \&DM) and block randomized.
Who cannot join
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
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- A gastric mass or gastric polyps > 1 cm in size.
- A hiatal hernia > 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
- A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
- Achalasia or any other severe esophageal motility disorder
- Severe coagulopathy (INR >1.5) or on anticoagulation therapy.
- Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C ≥ > 9.
- Diabetics who are treated with GLP-1 and have lost 5% or more of their weight (%TBWL ≥ 5%).
- Patients who discontinued GLP-1 therapy and regained less than 80% of the weight they had lost prior to starting GLP-1 treatment and within 3 months of discontinued GLP-1 therapy.
- Patients with any serious health condition unrelated to their weight that would increase the risk of endoscopy
- Chronic abdominal pain
- Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
- Hepatic insufficiency or cirrhosis
- Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
- Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
- Patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with high dose aspirin (> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
- Patients who are pregnant or breast-feeding.
- Patients with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 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
- Patients who are taking diet pills
- Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
- Specific diagnosed genetic disorder such as Prader Willi syndrome.
- 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
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Sara Karameh, Study Coordinator, 202-948-6396, Sara.Karameh@cshs.org
Barham Abu Dayyeh, MD
- Recruiting
Weill Cornell -1300 York Avenue
New York, New York, 10065
Oliver Laguerre, Assistant Research Coordinator, 646-962-2085, oll4007@med.cornell.edu
Reem Z Sharaiha, MD
- Recruiting
Lenox Hill Hospital | Northwell Health
New York, New York, 10075
Steven Shamah, MD, 973-699-9328, steven.shamah@gmail.com
Steven Shamah, MD
- Recruiting
Orlando Health, Inc.
Orlando, Florida, 32806
Leticia s Morales, MHA, CCRP Supervisor, 321-841-9623, Leticia.Morales@orlandohealth.com
Andre Teixeira, MD
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Vincenzo Bove, MD, PhD, +39 333 4451262, vincenzo.bove@policlinicogemelli.it
Ivo Boskoski, MD, PhD
About this study
Official title: Comparing the Efficacy and Safety of the EndoZipTM System and Apollo Endoscopic Sleeve Gastroplasty (ESG), Followed by Behavioral Modifications, in Obese Patients Who Have Not Achieved Weight Reduction Through Non-surgical Methods.
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
Read the detailed description
randomized, multicenter, prospective, two-arms, blinded, clinical study will include up to 184 patients (up to 30 patients per site), aimed at evaluating the safety and effectiveness of the EndoZip system procedure, compared to the Apollo ESG procedure, in obese patients who failed to reduce weight with non-surgical weight-loss methods.
Patients will be enrolled at up to 10 clinical sites in US and Europe. Patients who meet the eligibility criteria will be follow up for 12 months.
- Conditions
- Obesity, Overweight
- Being tested
- EndoZip System, OverStitch Endoscopic Suturing System (ESG)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoZip SystemDevice
The EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach.
OverStitch Endoscopic Suturing System (ESG)Device
The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach.
| Study group | Role | What they receive |
|---|---|---|
| EndoZip System | Experimental | The EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach. Receives: Device: EndoZip System |
| OverStitch Endoscopic Suturing System | Active comparator | Description: The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach. Receives: Device: OverStitch Endoscopic Suturing System (ESG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B.
Measured: 12 months
Percentage of patients in Group A with a reduction in %TBWL of at least 5% at 12 months
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 posted29 Jul 2025
- Study start14 Nov 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The EndoZip system is a single-use device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach. The device is intended to be used in adult patients with obesity who have a body mass index (BMI) of 30-40 50 kg/m2 and who have not been able to lose weight or maintain weight loss through more conservative measures. The system uses an automated a minimally invasive approach to form wall-to-wall longitudinal attachments anterior and posterior stomach walls, creating multiple plications within.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitinotes Surgical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090005
- Sponsor's protocol ID
- CL00020
- Acronym
- ESG
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of the EndoZipTM System and Apollo Endoscopic Sleeve Gastroplasty (ESG), Followed by Behavioral Modifications, in Obese Patients Who Have Not Achieved Weight Reduction Through Non-surgical Methods.
- ClinicalTrials.gov ID
- NCT07090005
- Acronym / sponsor ID
- ESG / CL00020
- Conditions
- Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Nitinotes Surgical Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
Detailed description
randomized, multicenter, prospective, two-arms, blinded, clinical study will include up to 184 patients (up to 30 patients per site), aimed at evaluating the safety and effectiveness of the EndoZip system procedure, compared to the Apollo ESG procedure, in obese patients who failed to reduce weight with non-surgical weight-loss methods.
Patients will be enrolled at up to 10 clinical sites in US and Europe. Patients who meet the eligibility criteria will be follow up for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The EndoZip system is a single-use device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach. The device is intended to be used in adult patients with obesity who have a body mass index (BMI) of 30-40 50 kg/m2 and who have not been able to lose weight or maintain weight loss through more conservative measures. The system uses an automated a minimally invasive approach to form wall-to-wall longitudinal attachments anterior and posterior stomach walls, creating multiple plications within.
| Arm | Type | Receives |
|---|---|---|
| EndoZip System | Experimental | Device: EndoZip SystemThe EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach. |
| OverStitch Endoscopic Suturing System | Active comparator | Device: OverStitch Endoscopic Suturing System (ESG)Description: The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 21-65
- BMI ≥ 30 and ≤50 kg/m².
- Willingness to comply with the substantial behavioral modifications and dietary restrictions as required by the procedure.
- 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 (34 listed)
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
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 EndoZip System is a single-use automated suturing device, designed to create multiple internal gastric segmentations in the stomach using an endoscopic approach. | Device | EndoZip System |
| OverStitch Endoscopic Suturing System (ESG)The OverStitch ESG is suturing device, designed to create manual suturing in the stomach using an endoscopic approach. | Device | OverStitch Endoscopic Suturing System |
Primary outcome
Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B.
Time frame: 12 months
Percentage of patients in Group A with a reduction in %TBWL of at least 5% at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 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 and OverStitch Endoscopic Suturing System (ESG) in people with Obesity and Overweight, run by Nitinotes Surgical Ltd. at 5 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 34 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ravit Peled (+972526145354, ravit@nitinotesurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B. (time frame: 12 months). 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?
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 1 Oct 2026.