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Effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty: a single-centre open-label, randomized, controlled pilot clinical trial
EU CTIS ID: 2024-517679-18-00
What this study is testing
To evaluate the effect of PPI’s on the structural integrity of the ESG
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 20 to 65 years
- BMI between 30 to 45 kg/m2
- Willingness to participate in the study and ability to comply and understand the study protocol
You likely can't join if
- Active gastric gastro-duodenal during the last 6 months
- Continuous glucocorticoid or anti-inflammatory treatment
- Uncontrolled thyroid disease
- Pregnancy, breastfeeding
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- Hiatal hernia ≥ 5 cm
See the full eligibility criteria
- Age 20 to 65 years
- BMI between 30 to 45 kg/m2
- Willingness to participate in the study and ability to comply and understand the study protocol
- Active gastric gastro-duodenal during the last 6 months
- Continuous glucocorticoid or anti-inflammatory treatment
- Uncontrolled thyroid disease
- Pregnancy, breastfeeding
- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- Hiatal hernia ≥ 5 cm
- Known allergy or hypersensitivity to the active substance or any of the other excipients
- Liver cirrhosis of any Child-Phugh stage or MELD> 15
- Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)
- Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
- Helicobacter pylori infection
- Organic or motility disorder of the stomach and / or esophagus
- Anticoagulant treatment
- Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- Ongoing or active malignancy during the last 5 years
- Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association’s classification
- Drug or alcohol abuse
- Bulimic or binge eating pattern
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.