Perceived quality of life after endoscopic vertical gastroplasty
Official title: Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty, a Descriptive Exploratory Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06839677 · Data updated 2026-11-12
This project tries to learn how adults in Italy feel about their quality of life at least six months after having endoscopic vertical gastroplasty.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | March 28, 2025 |
| Main results expected | February 18, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT06839677 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in Italy who are at least six months post-GVE, can understand and speak Italian, give informed consent, and have access to and basic competence with a computer or tablet are ideal candidates.
✕Probably not a fit
Patients less than six months after GVE, those without internet-enabled devices or Italian language proficiency, and those enrolled in other experimental GVE procedures are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicentre exploratory descriptive study led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS that uses a single semi-structured interview to capture patients' quality-of-life perceptions after endoscopic vertical gastroplasty (GVE). Eligible Italian adults must be at least six months post-GVE, able to give informed consent, and familiar with using a computer or tablet. Interviews are conducted remotely via Microsoft Teams, audio recorded, fully transcribed, and analyzed using NVivo v1.6.2 to identify themes and patterns in patient experiences.
Why it matters
Potential benefit: If successful, the findings could clarify how GVE affects day-to-day wellbeing and help clinicians counsel and support patients after the procedure.
How similar studies have gone: Previous studies of endoscopic gastroplasty have shown modest weight loss and mixed quality-of-life results, so the approach has some supporting data but its effect on long-term quality of life remains unclear.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: Patients older than 18 years. * Treatment: Patients who have undergone GVE surgery and have been in post- surgery for at least six months. * Access and technological competence: Patients who have a computer or tablet at home and are familiar with their use. * Informed consent: Patients who are able to understand and give informed consent informed consent to participate in the study. * Language comprehension: Patients who have a good understanding of the language Italian language, both written and spoken, to ensure correct completion and understanding of the informed consent and the study instructions. Exclusion Criteria: * Patients who have been enrolled in experimental studies involving additional procedures during GVE will be excluded
Where it's running
-
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Rm, Italy Recruiting
Study contacts
- Principal investigator: Chiara Massari — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Chiara Massari
- Email: chiara.massari@policlinicogemelli.it
- Phone: +393926669423
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.