CoChat
Sign Up
Cited by 162Bariatric Surgery and OutcomesVagus Nerve Stimulation ResearchPharmacology and Obesity Treatment

The EMPOWER Study: Randomized, Prospective, Double-Blind, Multicenter Trial of Vagal Blockade to Induce Weight Loss in Morbid Obesity

The EMPOWER Study Group, Sarr, Michael G., Billington, Charles J., Brancatisano, Roy, Brancatisano, Anthony, Toouli, James, Kow, Lilian, Nguyen, Ninh T. +15 more·2012·Obesity Surgery
DOI 10.1007/s11695-012-0751-8
Open this paper in CoChat — free account

Abstract

Background Intermittent, reversible intraabdominal vagal blockade (VBLOC® Therapy) demonstrated clinically important weight loss in feasibility trials. EMPOWER, a randomized, double-blind, prospective, controlled trial was conducted in USA and Australia.Methods Five hundred three subjects were enrolled at 15 centers. After informed consent, 294 subjects were implanted with the vagal blocking system and randomized to the treated (n = 192) or control (n = 102) group. Main outcome measures were percent excess weight loss (percent EWL) at 12 months and serious adverse events. Subjects controlled duration of therapy using an external power source; therapy involved a programmed algorithm of electrical energy delivered to the subdiaphragmatic vagal nerves to inhibit afferent/efferent vagal transmission. Devices in both groups performed regular, low-energy safety checks. Data are mean ± SEM.Results Study subjects consisted of 90 % females, body mass index of 41 ± 1 kg/m(2), and age of 46 ± 1 years. Device-related complications occurred in 3 % of subjects. There was no mortality. 12-month percent EWL was 17 ± 2 % for the treated and 16 ± 2 % for the control group. Weight loss was related linearly to hours of device use; treated and controls with ≥ 12 h/day use achieved 30 ± 4 and 22 ± 8 % EWL, respectively.Conclusions VBLOC® therapy to treat morbid obesity was safe, but weight loss was not greater in treated compared to controls; clinically important weight loss, however, was related to hours of device use. Post-study analysis suggested that the system electrical safety checks (low charge delivered via the system for electrical impedance, safety, and diagnostic checks) may have contributed to weight loss in the control group.

Integrity signals

Registry

Crossref · 10.1007/s11695-012-0751-8

Cites

14 of 14 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Related

Authors
The EMPOWER Study Group, Sarr, M. G., Billington, C. J., Brancatisano, R., Brancatisano, A., Toouli, J., Kow, L., Nguyen, N. T., Blackstone, R., Maher, J. W., Shikora, S., Reeds, D. N., Eagon, J. C., Wolfe, B. M., O’Rourke, R. W., Fujioka, K., Takata, M., Swain, J. M., Morton, J. M., Ikramuddin, S., Schweitzer, M., Chand, B., & Rosenthal, R.
Affiliations
  • Mayo Clinic (US)
  • University of Minnesota (US)
  • Circle of Care (AU)
  • Flinders University (AU)
  • University of California, Irvine (US)
  • Virginia Commonwealth University (US)
  • Tufts Medical Center (US)
  • Washington University in St. Louis (US)
  • Oregon Health & Science University (US)
  • Scripps Clinic (US)
  • Cleveland Clinic (US)
  • Cleveland Clinic Florida (US)
Corresponding author
Sarr, Michael G.
ORCID
Venue
Obesity Surgery
Publisher
Springer Science and Business Media LLC
Published
2012-09-08
Volume
22
Issue
11
Pages
1771-1782
ISSN
  • 0960-8923 (ISSN-L)
  • 1708-0428
DOI
10.1007/s11695-012-0751-8
OpenAlex
W2071260681
Cited by
162
References
14
Citations by year
2026: 3 · 2025: 8 · 2024: 2 · 2023: 11 · 2022: 10 · 2021: 15 · 2020: 13 · 2019: 10 · 2018: 20 · 2017: 16 · 2016: 24 · 2015: 15 · 2014: 10 · 2013: 4 · 2012: 1
FWCI
9.73
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • Obesity Surgery (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
  • Life Sciences › Neuroscience › Neurology › Vagus Nerve Stimulation Research
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
vagal blockade, morbid obesity
MeSH terms
Appetite, Australia, Autonomic Nerve Block, Double-Blind Method, Electrodes, Implanted, Electric Stimulation Therapy, Female, Humans, Hunger, Male, Middle Aged, Obesity, Morbid, Prospective Studies, Surveys and Questionnaires, United States, Vagus Nerve, Weight Loss, Body Mass Index, Treatment Outcome

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review