The Adjustable Intragastric Balloon for Treatment of Obesity: Results of a Multicenter, Randomized Controlled Trial

Abstract

Background: Intragastric balloons are anatomy preserving, minimally invasive therapies for obesity. Enhanced tolerance and durability inform clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) with prolonged dwelling time in adults with obesity.Methods: Patients were randomized to the Spatz3 (Spatz FGIA, Great Neck, NY) aIGB with lifestyle intervention versus lifestyle intervention alone (control) for 32 weeks. The aIGB volume could be increased to facilitate weight loss or decreased for tolerability. Co-primary endpoints included mean total body weight loss (TBL) and responder rate (≥ 5% TBL) at 32 weeks. Weight loss maintenance (WLM) was reported at 14 months. Improvement in obesity-related comorbidities was reported at 32 weeks. Data were analyzed in a multiple imputed intention to treat (miITT) population. Adverse events were recorded throughout the study duration.Findings: 288 adults with obesity were randomized to aIGB (n = 187) or control (n = 101) arms. Mean TBL was 15‧0% [95% CI 13‧9%, 16‧1%] in the aIGB group vs 3‧3% [95% CI 2‧0%,4‧6%] in controls (p Interpretation: The adjustable intragastric balloon induced significant weight loss that was maintained in most patients. Adjustability of volume significantly improved safety and tolerance highlighting advantages of this therapy for clinical practice.Trial Registration: This study was registered with clinicaltrial.gov -NCT02812160.Funding: SPATZ MedicalDeclaration of Interest: BKA reports consultant roles with Endogenex, Endo-TAGSS, Metamodix, and BFKW; consultant and grant/research support from USGI, Cairn Diagnostics, Aspire Bariatrics, Boston Scientific; Speaker roles with Olympus, Johnson and Johnson; speaker and grant/research support from Medtronic, Endogastric solutions; and research support from Apollo Endosurgery, and Spatz Medical. CGC reports consultant roles with Olympus; consultant roles and payment or honoraria Apollo Endosurgery, Boston Scientific; payment or honoraria from Abbive; participation in a Data Safety Monitoring Board and consultant roles with ERBE, BFKW Inc, and Nitinotes Surgical. VP reports consultancy fees from Obalon Therapeutics Inc. PJ reports grants from Boston Scientific; licenses to Endosim; consulting fees from Endogastric solutions, ERBE; support for meetings from USGI medical; consulting fees and research support from GI dynamics; research support from Apollo Endosurgery, and Fractyl. AA reports grants from NIH-NIDDK, American Neurogastroenterology and Motility Society, Mayo Clinic Center for Individualized Medicine; Stockholder of Gila Therapeutics, and Phenomix Sciences; personal fees from Rhythm Pharmaceuticals, General Mills, Gila Therapeutics; he reports patent PCT. US 62/589,915 licensed to Phenomix Sciences. ACS reports institutional research grants from Boston Scientific, Enterasense, Endogenex; consulting fees from Olympus; consulting fees and research grants from Endo-TAGSS, and Apollo Endosurgery; Participation in Data Safety Monitoring Board with GI Dynamics, and ERBE. MR reports consultant roles with Boston Scientific, Fujifilm, Medtronic, Enterasense, and GI Windows; Consultant and research support from Cook Medical. DM reports financial support from SPATZ medical for statistical analysis for this trial. CCT reports institutional research grants from Aspire Bariatrics, ERBE, SPATZ; Royalties from Endosim, Enterasense; Consulting fees and research grants from Apollo Endosurgery, Boston Scientific, Covidien/ Medtronic, Fractyl, Fujifilm, GI Dynamics, Lumendi, Olympus, and USGI; Payment or honoraria from Boston Scientific and Olympus; Patents licensed to Boston Scientific, GI Windows, Enterasense, EnVision Endoscopy, Endosim; Participation in Data Safety Monitoring Board with GI Dynamics, Fractyl, USGI; Leadership or fiduciary role in other board with Enterasense, EnVision Endoscopy, GI Windows, ASGE Governing board, BlueFlame Healthcare Venture Fund; Stockholder in GI Windows, Enterasense, EnVision Endoscopy; has received equipment on loan from Fujifilm, Olympus, and Boston Scientific. All other authors report no conflict of interests.Ethical Approval: It was conducted under a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE G160061), approved on 29-Jul-2016, in compliance with 21 CFR812