Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients (NCT07090005) | Clinical Trial Compass
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.
Who can participate
Age range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean percent of total body weight loss (%TBWL) after 12 months in Group A patients versus Group B.
Timeframe: 12 months
2
Percentage of patients in Group A with a reduction in %TBWL of at least 5% at 12 months
. 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.