NCT06283381 The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
| NCT ID | NCT06283381 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2024-02-01 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms: * Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure. * Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment). The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * Active gastric gastro-duodenal during the last 6 months * 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 * 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.
Frequently Asked Questions
Who can join the NCT06283381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06283381 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06283381 currently recruiting?
Yes, NCT06283381 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione Policlinico Universitario Agostino Gemelli IRCCS to inquire about joining.
Where is the NCT06283381 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06283381 clinical trial?
NCT06283381 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 40 participants.
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