Adjustable-Intragastric-Balloon versus Standard Intragastric balloon plus lifestyle modification. A Randomized Head-to-Head Trial

Adjustable-Intragastric-Balloon versus Standard Intragastric balloon plus lifestyle modification. A Randomized Head-to-Head Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Adjustable-Intragastric-Balloon versus Standard Intragastric balloon plus lifestyle modification. A Randomized Head-to-Head Trial Evzen Machytka, Roberto Simons-Linares, Adam Vasura, Martin Blaho, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9193515/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Background Intragastric balloons (IGBs) have been used for over 40 years. There has never been a prospective randomized head-to-head comparison study between intra-gastric balloon types. Methods Prospective randomized open-label trial at a single institution. Modified intention-to-treat (ITT) analysis was performed. Forty-three patients were randomized 1:1 to receive either a standard 6-month intragastric balloon (IGB) [Orbera, Boston Scientific] followed by 6-month dietitian follow-up or a 12-month adjustable intragastric balloon (AIGB) [Spatz3, Spatz Medical] with an adjustment procedure allowed during the 12-month period. The primary endpoint was total body weight loss (%TBWL) at 12 months. Results Twenty-one patients received IGB (mean age 44 years; mean weight 108.5 kg; mean BMI 37.0 kg/m²; mean balloon volume 500 ml). Twenty-two patients received AIGB (mean age 41 years; mean weight 103.6 kg; mean BMI 35.5 kg/m²; mean starting balloon volume 500 ml). Fourteen AIGB patients underwent up-volume adjustment at week 24 ± 6 weeks, with a mean volume increase of 282 ml (SD 37.2 ml). At 6 months, mean %TBWL was 8.7% for IGB and 9.9% for AIGB. At 12 months, mean %TBWL was 5.3% for IGB and 11.3% for AIGB. After balloon adjustment, %TBWL increased from 10% to 13% in adjusted AIGB patients. Conclusion In this randomized head-to-head trial, the 12-month adjustable intragastric balloon achieved significantly greater weight loss at 12 months compared with the standard 6-month intragastric balloon followed by dietitian follow-up. Balloon volume adjustment was associated with additional weight loss and may represent an effective strategy for optimizing intragastric balloon therapy. Health sciences/Gastroenterology Health sciences/Medical research intragastric balloon adjustable intragastric balloon obesity metabolic endoscopy bariatric endoscopy Figures Figure 1 Full Text Additional Declarations No competing interests reported. Tables 1 to 5 are available in the Supplementary Files section. Supplementary Files Tables.docx CONSORT2025.docx 00EK2.12.202025220stanoviskoopravenosloprotokoludne12.2.2021.pdf ClinicalProtocol52wkSpatz3OrberaVersion1.1signed.pdf Cite Share Download PDF Status: Under Review Version 1 posted Reviewers invited by journal 08 Apr, 2026 Editor assigned by journal 07 Apr, 2026 Editor invited by journal 02 Apr, 2026 Submission checks completed at journal 01 Apr, 2026 First submitted to journal 01 Apr, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9193515","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":620076340,"identity":"167bde8e-8e68-4dab-9f8c-dca12373fbbe","order_by":0,"name":"Evzen Machytka","email":"","orcid":"","institution":"EndoHope Gastroenterology","correspondingAuthor":false,"prefix":"","firstName":"Evzen","middleName":"","lastName":"Machytka","suffix":""},{"id":620076341,"identity":"839ac913-ee01-4fc5-8d97-222c9ad1798c","order_by":1,"name":"Roberto Simons-Linares","email":"","orcid":"","institution":"Cleveland 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A Randomized Head-to-Head Trial\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"intragastric balloon, adjustable intragastric balloon, obesity, metabolic endoscopy, bariatric endoscopy","lastPublishedDoi":"10.21203/rs.3.rs-9193515/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9193515/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIntragastric balloons (IGBs) have been used for over 40 years. There has never been a prospective randomized head-to-head comparison study between intra-gastric balloon types.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProspective randomized open-label trial at a single institution. Modified intention-to-treat (ITT) analysis was performed. Forty-three patients were randomized 1:1 to receive either a standard 6-month intragastric balloon (IGB) [Orbera, Boston Scientific] followed by 6-month dietitian follow-up or a 12-month adjustable intragastric balloon (AIGB) [Spatz3, Spatz Medical] with an adjustment procedure allowed during the 12-month period. The primary endpoint was total body weight loss (%TBWL) at 12 months.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTwenty-one patients received IGB (mean age 44 years; mean weight 108.5 kg; mean BMI 37.0 kg/m²; mean balloon volume 500 ml). Twenty-two patients received AIGB (mean age 41 years; mean weight 103.6 kg; mean BMI 35.5 kg/m²; mean starting balloon volume \u0026nbsp;500 ml). Fourteen AIGB patients underwent up-volume adjustment at week 24 ± 6 weeks, with a mean volume increase of 282 ml (SD 37.2 ml). At 6 months, mean %TBWL was 8.7% for IGB and 9.9% for AIGB. At 12 months, mean %TBWL was 5.3% for IGB and 11.3% for AIGB. After balloon adjustment, %TBWL increased from 10% to 13% \u003cbr\u003e\nin adjusted AIGB patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this randomized head-to-head trial, the 12-month adjustable intragastric balloon achieved significantly greater weight loss at 12 months compared with the standard \u0026nbsp;6-month intragastric balloon followed by dietitian follow-up. Balloon volume adjustment was associated with additional weight loss and may represent an effective strategy \u0026nbsp;for optimizing intragastric balloon therapy.\u003c/p\u003e","manuscriptTitle":"Adjustable-Intragastric-Balloon versus Standard Intragastric balloon plus lifestyle modification. 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