RecruitingNot Applicable

Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients

United States184 participantsStarted 2025-11-14

Plain-language summary

evaluation of the EndoZip system procedure compared to the Apollo ESG procedure in obese patients.

Age range21 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.
✕. 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.

Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B.

Timeframe: 12 months

Percentage of patients in Group A with a reduction in %TBWL of at least 5% at 12 months

Timeframe: 12 months

NCT IDNCT07090005

SponsorNitinotes Surgical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-01

Ravit Peled

Who can participate

Age range21 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.
✕. 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.