Balloon Treatment For Obesity Research Articles

Adjustable intragastric balloon for treatment of obesity: a multicentre, open-label, randomised clinical trial

Intragastric balloons are anatomy-preserving, minimally invasive obesity therapies. Enhanced tolerance and durability could help broaden clinical adoption. We investigated the safety and efficacy of an adjustable intragastric balloon (aIGB) in adults with obesity. In this prospective, multicentre, open-label, randomised clinical trial done at seven US sites, adults aged 22-65 years with obesity were randomly assigned (2:1) to aIGB with lifestyle intervention or lifestyle intervention alone (control) for 32 weeks. Balloon volume could be increased to facilitate weight loss or decreased for tolerability. Coprimary endpoints included mean percentage total bodyweight loss and responder rate (≥5% total bodyweight loss) at 32 weeks. We used a multiple imputed intention-to-treat population analysis. This study was registered with ClinicalTrials.gov, NCT02812160. Between Aug 9, 2016, and Dec 7, 2018, we randomly assigned 288 patients to aIGB (n=187 [65%]) or control (n=101 [35%]) groups. Mean total bodyweight loss at 32 weeks was 15·0% (95% CI 13·9-16·1) in the aIGB group versus 3·3% (2·0-4·6) in the control group (p<0·0001). Clinical response was observed in 171 (92%) patients in the aIGB group. Adjustments to the aIGB occurred in 145 (80%) patients for weight loss plateau or intolerance. Upward volume adjustment facilitated an additional mean 5·2% (4·5-5·8) total bodyweight loss. Downward volume adjustment allowed 21 (75%) patients in the aIGB group to complete the full duration of therapy. Intolerance caused early removal of the device in 31 (17%) patients. No micronutrient deficiencies were observed in the aIGB cohort. Device-related serious adverse events were observed in seven (4%) patients, without any deaths. When aIGB was combined with lifestyle modification, significant weight loss was achieved and maintained for 6 months following removal. Balloon volume adjustability permitted individualised therapy, maximising weight loss and tolerance. Spatz Medical.

A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial

Background and aims Obesity with type-2 diabetes is a global challenge. Lifestyle interventions have limited effect for most patients. Bariatric surgery is highly effective, but resource-demanding, invasive and associated with serious complications. Recently, a new intragastric balloon was introduced, not requiring endoscopy for placement or removal (Elipse™, Allurion Inc., Natick, MA). The balloon is swallowed in a capsule and filled with water once in the stomach. The balloon self-deflates after 4 months and is naturally excreted. The present trial investigated balloon feasibility, safety and efficacy in patients with obesity and type-2 diabetes. Patients and methods We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0–39.9 kg/m2 at two Norwegian centers with the Elipse balloon. Patient follow-up during balloon treatment mimicked real-world clinical practice, including dietary plan and outpatient visits. The primary efficacy endpoints were total body weight loss (TBWL) and HbA1c at weeks 16 and 52. Results All patients underwent balloon insertion uneventfully as out-patients. Mean TBWL and HbA1c reduction after 16 and 52 weeks of balloon insertion was 3.9% (95%CI 2.1–5.7) and 0.8% (95%CI 1.9–3.5); and 7 (95%CI 4–10), and 1 (95%CI −6 to 9) mmol/mol, respectively. Adverse events occurred in two patients (10.5%): one developed gastric outlet obstruction, managed by endoscopic balloon removal; the other excessive vomiting and dehydration, managed conservatively. Conclusions This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.

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

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

Can Metabolic and Hepatic Abnormalities Be Improved by Intragastric Balloon Treatment for Obesity?

Can Metabolic and Hepatic Abnormalities Be Improved by Intragastric Balloon Treatment for Obesity?

Intragastric balloon for treatment of obesity: Preliminary results

Intragastric balloon for treatment of obesity: Preliminary results