Evidence map›Paper›PMID 27506803›Full record

Trial reportObesity surgery2017

Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.

Caroline M Apovian, Sajani N Shah, Bruce M Wolfe, Sayeed Ikramuddin, Christopher J Miller, Katherine S Tweden, Charles J Billington, Scott A Shikora

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity surgery, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01327976 (A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity), which is not on this map. Cited by 78 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 3 pooled it
8.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01327976 naunknown statusnot on this map

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Safety and Efficacy of vBloc Therapy Delivered by the Maestro Rechargeable System for the Treatment of Obesity

TypeinterventionalSponsorReShape LifesciencesRan2011 to 2021Enrolled239ConditionsObesityArmsvBloc (Active Device), Sham (Non-active Device)
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 3 syntheses or guidelines pooled it, 147 citations in OpenAlex.

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  8. Lymphocyte Antigen 6G Mediates Vagotomy-Associated Reduction in Body Weight.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
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18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 1 country.

Caroline M ApovianBoston University School of Medicine, 88 East Newton Street, Boston, MA, 02118, USA.
Sajani N ShahTufts Medical Center, Boston, 800 Washington St, Boston, MA, 02111, USA.
Bruce M WolfeOregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.
Sayeed IkramuddinUniversity of Minnesota, 420 Delaware St, Minneapolis, MN, 55455, USA.
Christopher J Miller3D Communications, LLC, 8386 Six Forks Rd, Raleigh, NC, 27615, USA.
Katherine S TwedenEnteroMedics Inc., 2800 Patton Road, St. Paul, MN, 55113, USA. ktweden@enteromedics.com.
Charles J BillingtonUniversity of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans Drive, Minneapolis, MN, 55417, USA.
Scott A ShikoraBrigham and Women's Hospital, 75 Francis Street, Boston, MA, 02115, USA.
University of Minnesota · USBoston University · USBrigham and Women's Hospital · USOregon Health & Science University · USReShape Lifesciences (United States) · USTufts Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes.

methodsParticipants with body mass index (BMI) 40 to 45 kg/m

resultsAt 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3 %), and systolic (-11 mmHg) and diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %.

conclusionsvBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years.

trial registrationhttps://clinicaltrials.gov/ct2/show/NCT01327976.

Indexed as

Electric Stimulation TherapyElectrodes, ImplantedAdultAutonomic Nerve BlockCross-Over StudiesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedObesity, MorbidQuality of LifeRisk FactorsTreatment OutcomeVagus NerveObesityQuality of lifeVagal nerve blockingWeight loss surgery

Identifiers

PMID27506803
PMCPMC5187356
OpenAlexW2513083063

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.