Actively Recruiting
Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
Led by Nitinotes Surgical Ltd. · Updated on 2026-01-21
184
Participants Needed
2
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.
CONDITIONS
Official Title
Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 65 years
- Body mass index (BMI) between 30 and 50 kg/m²
- Willing to follow substantial behavioral and dietary changes required by the procedure
- History of unsuccessful weight loss with non-surgical methods
- Willing to complete informed consent, follow-up visits, lab tests, questionnaires, and supervised diet and behavior program
- Living within reasonable travel distance to the study site
- Able to give informed consent
- Women of childbearing potential must agree to use effective birth control
- Study includes quotas for patients with controlled hypertension and type II diabetes managed with oral medications
You will not qualify if you...
- History of foregut or gastrointestinal surgery except simple gallbladder or appendix removal
- Prior gastrointestinal surgery causing complications like obstruction or adhesions
- Previous bariatric surgery
- Surgery on esophagus, stomach, or hiatal hernia
- Inflammatory gastrointestinal diseases or specific conditions like Crohn's disease
- Conditions increasing risk of upper gastrointestinal bleeding
- Gastric masses or polyps larger than 1 cm
- Hiatal hernia larger than 4 cm or severe reflux symptoms
- Structural abnormalities of esophagus or pharynx blocking endoscope passage
- Severe esophageal motility disorders
- Severe blood clotting problems or on anticoagulants
- Insulin-dependent diabetes or poorly controlled diabetes (HgbA1c ≥ 9)
- Recent or ongoing GLP-1 therapy with significant weight loss
- Serious unrelated health conditions increasing endoscopy risk
- Chronic abdominal pain or gastrointestinal motility disorders
- Liver failure or cirrhosis
- Prior intragastric device use
- Active psychological issues preventing participation
- Unwillingness to participate in supervised diet and behavior program
- Use of high-dose aspirin, anti-inflammatory, anticoagulant, or gastric irritant medications
- Pregnant or breastfeeding
- Severe heart or lung diseases
- Use of medications affected by gastric emptying changes
- Use of corticosteroids, immunosuppressants, narcotics, or diet pills
- Symptomatic heart failure or unstable coronary artery disease
- Pre-existing respiratory diseases
- Autoimmune connective tissue disorders or immunocompromised state
- Specific genetic disorders like Prader-Willi syndrome
- Eating disorders such as bulimia or binge eating
- Endocrine disorders affecting weight like uncontrolled hypothyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
2
Lenox Hill Hospital | Northwell Health
New York, New York, United States, 10075
Actively Recruiting
Research Team
R
Ravit Peled
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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