Evidence map›Paper›PMID 29333595›Full record

Trial reportObesity surgery2018

Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

S Morales-Conde, I Alarcón Del Agua, L Busetto, F Favretti, M Anselmino, G M Rovera, M Socas-Macias, A Barranco-Moreno, R Province-Azalde, A J Torres

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Obesity surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01448785 (Abiliti™ Treatment in Obese Subjects), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

NCT01448785 naunknown statusnot on this map

Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study

TypeinterventionalSponsorIntraPace, IncRan2011 to 2015Enrolled165ConditionsObesity, Morbid ObesityArmsabiliti system implant, Laparoscopic adjustable gastric band (Allergan Lap Band)
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Electroceuticals in the Gastrointestinal Tract.Trends in pharmacological sciences · 2020
    Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

S Morales-CondeInnovation and Minimal Invasive Surgery Unit, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain.
I Alarcón Del AguaInnovation and Minimal Invasive Surgery Unit, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain.
L BusettoDepartment of Medicine - University of Padova, Center for the Study and the Integrated Management of Obesity, Clinica Medica 3 - Padova University Hospital, Via Giustiniani 2, 35128, Padova, Italy.
F FavrettiPrimari Vicenza Regional Hospital, Casa di cura Eretenia, Viale Eretenio 12, 36100, Vicenza, Italy.
M AnselminoBariatric Surgery Department, University Hospital Pisa, Via Roma, 67, 56126, Pisa, Italy.
G M RoveraClinica San Luca Torino, Strada della Vetta 3, 10020, Torino, Italy.
M Socas-MaciasInnovation and Minimal Invasive Surgery Unit, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain.
A Barranco-MorenoInnovation and Minimal Invasive Surgery Unit, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain.
R Province-AzaldeIntraPace Inc., 169 S 12th St, San Jose, CA, 95112, USA.
A J TorresDepartment of Surgery, Hospital Clínico San Carlos. Hospital Universitario Madrid Monteprincipe, Calle Profesor Martín Lagos s/n, 28040, Madrid, Spain. ajtorresgarcia@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWeight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare.

methodsFour centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed.

resultsWeight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months.

conclusionDuring the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits.

trial registrationClinicalTrials.gov identifier: NCT01448785.

Indexed as

Bariatric SurgeryElectric Stimulation TherapyFeedback, PhysiologicalHumansObesity, MorbidProspective StudiesProsthesis ImplantationStomachWeight GainEating behaviorGastric stimulationMorbid obesityObesityWeight loss

Identifiers

PMID29333595

What OpenQuestion holds

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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.