ObesityPhase 4ESGISNCT06283381
The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty
A Phase 4 study testing Esomeprazole in people with Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
IVO BOSKOSKI, +390630155701, ivo.boskoski@policlinicogemelli.it
IVO BOSKOSKI
About this study
Official title: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial
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
- Conditions
- Obesity
- Being tested
- Esomeprazole
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
oral administration, tablets, 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Arm A: experimental group | Experimental | no administration of Esomeprazole or any other proton pump inhibitor after the Endoscopic Sleeve Gastroplasty Receives: Drug: Esomeprazole |
| Arm B: standard of care group | Active comparator | administration of Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for another 4 weeks after the Endoscopic Sleeve Gastroplasty Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)
The structural integrity of the ESG will be defined as opened (all stitches loose), partially intact (at least one stitch loose), or intact (all stitches tight).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283381
- Sponsor's protocol ID
- 4264
- Acronym
- ESGIS
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT06283381
- Acronym / sponsor ID
- ESGIS / 4264
- Conditions
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: experimental group | Experimental | Drug: Esomeprazoleno administration of Esomeprazole or any other proton pump inhibitor after the Endoscopic Sleeve Gastroplasty |
| Arm B: standard of care group | Active comparator | Drug: Esomeprazoleadministration of Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for another 4 weeks after the Endoscopic Sleeve Gastroplasty |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazoleoral administration, tablets, 40 mg | Drug | Arm A: experimental group, Arm B: standard of care group |
Primary outcome
The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG)
Time frame: 6 months
The structural integrity of the ESG will be defined as opened (all stitches loose), partially intact (at least one stitch loose), or intact (all stitches tight).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with Obesity, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.