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Compares treatment options for Obesity
Official title Comparing the Efficacy and Safety of the EndoZip System and Apollo ESG in Obese Patients
ClinicalTrials.gov ID: NCT07090005
What this study is testing
- What it's testing
- The study aims to find out how well the EndoZip system works compared to the Apollo Endoscopic Sleeve Gastroplasty (ESG) for weight loss.
- Who it's for
- The study is looking for obese patients who are considering weight loss procedures.
- What's involved
- Participants will undergo either the EndoZip system procedure or the Apollo ESG procedure to see which is more effective.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- 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...
You likely can't join if
- 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...
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or...
See the full eligibility criteria
Who can 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...
- 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.
- \ \ \ 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...
What rules you out
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.