2016
Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study
Morton JM, Shah SN, Wolfe BM, Apovian CM, Miller CJ, Tweden KS, Billington CJ, Shikora SA. Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study. Obesity Surgery 2016, 26: 983-989. PMID: 27048437, PMCID: PMC4831996, DOI: 10.1007/s11695-016-2143-y.Peer-Reviewed Original ResearchConceptsObesity-related comorbid conditionsBody mass indexModerate obesityComorbid conditionsPercentage excess weight lossWeight lossImplant site painVagal nerve blockadeCommon adverse eventsExcess weight lossObesity-related comorbiditiesWeight management counselingType 2 diabetesGreater weight lossSite painAdverse eventsBlockade therapyPrespecified subgroupsSevere obesitySham deviceMass indexNerve blockadeSleep apneaSafety profileClinical trials
2014
Effect of Reversible Intermittent Intra-abdominal Vagal Nerve Blockade on Morbid Obesity: The ReCharge Randomized Clinical Trial
Ikramuddin S, Blackstone RP, Brancatisano A, Toouli J, Shah SN, Wolfe BM, Fujioka K, Maher JW, Swain J, Que FG, Morton JM, Leslie DB, Brancatisano R, Kow L, O’Rourke R, Deveney C, Takata M, Miller CJ, Knudson MB, Tweden KS, Shikora SA, Sarr MG, Billington CJ. Effect of Reversible Intermittent Intra-abdominal Vagal Nerve Blockade on Morbid Obesity: The ReCharge Randomized Clinical Trial. JAMA 2014, 312: 915-922. PMID: 25182100, DOI: 10.1001/jama.2014.10540.Peer-Reviewed Original ResearchConceptsExcess weight lossNerve block groupPrimary safety objectiveWeight lossMorbid obesityAdverse eventsSham groupClinical trialsEfficacy objectiveMean percentage excess weight lossBlock groupPercentage excess weight lossSerious adverse event ratesSham-controlled clinical trialSham device groupVagal nerve blockadeWeight management educationSerious adverse eventsBariatric surgery resultsLong-term morbidityAdverse event ratesObesity-related conditionsNerve block therapyBody mass indexAbdominal pain
2012
The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity
Sarr MG, Billington CJ, Brancatisano R, Brancatisano A, Toouli J, Kow L, Nguyen NT, Blackstone R, Maher JW, Shikora S, Reeds DN, Eagon JC, Wolfe BM, O’Rourke R, Fujioka K, Takata M, Swain JM, Morton JM, Ikramuddin S, Schweitzer M, Chand B, Rosenthal R, The EMPOWER Study Group. The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity. Obesity Surgery 2012, 22: 1771-1782. PMID: 22956251, DOI: 10.1007/s11695-012-0751-8.Peer-Reviewed Original ResearchConceptsImportant weight lossControl groupWeight lossMorbid obesityVagal blockadePercent excess weight lossSubdiaphragmatic vagal nerveExcess weight lossSerious adverse eventsDuration of therapyDevice-related complicationsBody mass indexMain outcome measuresDevice useResultsStudy subjectsVagal transmissionAdverse eventsVagal nerveMulticenter trialMass indexFeasibility trialEMPOWER studyOutcome measuresInformed consentTherapy