Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II … (NCT03493620) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Results of Endoscopic Gastroplasty Using Overstitch in Patients With Class I and II Obesity
Brazil60 participantsStarted 2018-01-08
Plain-language summary
Obesity is a chronic disease that has grown to epidemic proportions in Brazil and throughout the world in recent years. Bariatric surgery has been the most effective method for the treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the longevity and quality of life of patients. The treatment of patients with Class III obesity or higher or Class II with comorbidities is already well established with bariatric surgery being the best option. However, there is no consensus as to the best treatment in cases of Class I or II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures.
Who can participate
Age range
18 Years – 90 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:
* Aged over 18 years,
* BMI \> 30 and \< 36 kg/m2, with or without comorbidities,
* BMI \> 36 and \< 40 without comorbidities
Exclusion Criteria:
* Previous gastric surgery
* Taking anticoagulant drugs
* Psychiatric disorders
* Severe esophagitis
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.