Evidence map›Paper›PMID 26537905›Full record

Trial reportSurgical endoscopy2016

Long-term follow-up results of endoscopic treatment of gastroesophageal reflux disease with the MUSE™ endoscopic stapling device.

Hong Joo Kim, Chang-Il Kwon, William R Kessler, Don J Selzer, Gail McNulty, Amol Bapaye, Luigi Bonavina, Glen A Lehman

2 registry-linked trialsOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Surgical endoscopy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.8field-weighted citation impact, top 7% 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.

NCT00734747 phase3completednot on this map

Evaluation of the Medigus SRS Endoscopic Stapling System for the Treatment of Gastro-Esophageal Reflux Disease (GERD)

TypeinterventionalSponsorAviel Roy-Shapira, M.D.Ran2008 to 2015Enrolled72ConditionsGastroesophageal Reflux Disease (GERD)ArmsMedigus SRS endoscopic stapling system
NCT02366169 unknown statusnot on this map

A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD

Typeobservational_patient_registrySponsorMedigus LtdRan2015 to 2019Enrolled200ConditionsGastroesophageal Reflux Disease (GERD)ArmsMedigus Ultrasonic Surgical Endostapler (MUSE) Procedure
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 72 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
  5. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: methodology and review of evidence.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025
    Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Endoscopic Treatments of GERD.Current treatment options in gastroenterology · 2018
    Review
  18. Review
  19. New Approaches to Gastroesophageal Reflux Disease.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2017
    Article
  20. Review
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

8 authors at 6 institutions in 4 countries.

Hong Joo KimDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
Chang-Il KwonDigestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
William R KesslerDivision of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 550 N University Blvd, UH1634, Indianapolis, IN, 46202, USA.
Don J SelzerDivision of General Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
Gail McNultyDivision of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 550 N University Blvd, UH1634, Indianapolis, IN, 46202, USA.
Amol BapayeShivanand Desai Center for Digestive Disorders, Deenanath Mangeshkar Hospital and Research Center, Pune, India.
Luigi BonavinaDivision of General Surgery, University of Milan Medical School, Milan, Italy.
Glen A LehmanDivision of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, 550 N University Blvd, UH1634, Indianapolis, IN, 46202, USA. glehman@iupui.edu.
Indiana University – Purdue University Indianapolis · USIndiana University School of MedicineCHA University Bundang Medical Center · KRDeenanath Mangeshkar Hospital and Research Center · INKangbuk Samsung Hospital · KRUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe initial 6-month data for MUSE™ (Medigus, Omer, Israel) endoscopic stapling device were reported (Zacherl et al. in Surg Endosc 29:220-229, 2015). The current study aims to evaluate the long-term clinical outcome of 37 patients who received endoscopic gastroesophageal reflux disease (GERD) treatment with the MUSE™ device.

methodsEfficacy and safety data for 37 patients were analyzed at baseline, 6 months, and 4 years post-procedure. In one center (IU), efficacy and safety data were evaluated at baseline, 6 months post-procedure, and then annually up to 4 years.

resultsNo new complications have been reported in our long-term analysis. The proportions of patients who remained off daily PPI were 83.8 % (31/37) at 6 months and 69.4 % (25/36) at 4 years post-procedure. GERD-Health Related Quality of Life (HRQL) scores (off PPI) were significantly decreased from baseline to 6 months and 4 years post-procedure. The daily dosage of GERD medications, measured as omeprazole equivalents (mean ± SD, mg), decreased from 66.1 ± 33.2 at baseline to 10.8 ± 15.9 at 6 months and 12.8 ± 19.4 at 4 years post-procedure (P < 0.01).

conclusionsIn our multi-center prospective study, the MUSE™ stapling device appears to be safe and effective in improving symptom scores as well as reducing PPI use in patients with GERD. These results appeared to be equal to or better than those of the other devices for endoluminal GERD therapy. Future studies with larger patient series, sham control group, and greater number of staples are awaited.

Indexed as

Endoscopy, GastrointestinalSurgical StaplersAdultDrug UtilizationFemaleFollow-Up StudiesGastroesophageal RefluxHumansMaleMiddle AgedOmeprazoleProspective StudiesProton Pump InhibitorsQuality of LifeOmeprazoleProton Pump InhibitorsEndoscopic stapling deviceGastroesophageal reflux diseaseGERD-HRQLMUSE™Proton pump inhibitor

Identifiers

PMID26537905
PMCPMC4956714
OpenAlexW2226426976

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.