Evidence map›Paper›PMID 29602998›Full record

Trial reportSurgical endoscopy2018

Clinical feasibility of a new full-thickness endoscopic plication device (GERDx™) for patients with GERD: results of a prospective trial.

Michael Weitzendorfer, Georg O Spaun, Stavros A Antoniou, Kai Witzel, Klaus Emmanuel, Oliver O Koch

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Surgical endoscopy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.6field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  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. Problems with repairing gut sphincters malfunctions.World journal of gastrointestinal surgery · 2024
    Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. A novel technique to treat dysphagia after endoscopic full-thickness plication for managing gastroesophageal reflux disease.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2020
    Article
  17. Review
  18. Endoscopic treatment of GERD: is there still a chance?Endoscopy international open · 2019
    Article
  19. 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

6 authors at 3 institutions in 3 countries.

Michael WeitzendorferDepartment of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria. m.weitzendorfer@salk.at.ORCID 0000-0003-1657-7405
Georg O SpaunDepartment of Surgery, Ordensklinikum Linz Barmherzige Schwestern, Linz, Austria.
Stavros A AntoniouDepartment of General Surgery, 401 Military Hospital, Athens, Greece.
Kai WitzelDepartment of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria.
Klaus EmmanuelDepartment of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria.
Oliver O KochDepartment of Surgery, Paracelsus Medical University, 5020, Salzburg, Austria.
Paracelsus Medical University · AT401 General Military Hospital of Athens · GROrdensklinikum Linz Barmherzige Schwestern · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious studies suggest clinical effectiveness of endoscopic full-thickness plication in selected patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the clinical safety and efficiency of the GERDx™ device by evaluating clinical parameters, reflux symptom scores, and quality of life (QoL).

methodsProspective one-arm trial evaluating the outcome of forty patients with GERD subjected to endoscopic plication with the GERDx™ device. We included patients with at least one typical reflux symptom despite treatment with a PPI for > 6 months, pathologic esophageal acid exposure, hiatal hernia of size < 2 cm, and endoscopic Hill grade II-III. Evaluation of Gastrointestinal Quality of Life Index (GIQLI), symptom scores, esophageal manometry, and impedance-pH-monitoring were performed at baseline and at 3 months after surgery. (Trial Registration: ClinicalTrials.gov NCT 01798212.)

resultsThere were no intraoperative complications. Four out of forty patients experienced postoperative complications requiring intervention. Seven of forty patients were subjected to laparoscopic fundoplication 3 months after endoscopic plication due to persistent symptoms and were lost to further follow-up. Thirty out of forty patients were available at 3-month follow-up. There was an improvement of the GIQLI score, from a mean of 92.45 ± 18.47 to 112.03 ± 13.11 (p < 0.001). The general reflux-specific score increased from a mean of 49.84 ± 24.83 to 23.93 ± 15.63 (p < 0.001), and the DeMeester score from a mean of 46.48 ± 30.83 to 20.03 ± 23.62 (p < 0.001). There was no significant change in manometric data after intervention. Three of thirty patients continued daily antireflux medication.

conclusionsEndoscopic plication with the GERDx™ device reduced distal acid exposure of the esophagus, reflux-related symptoms, and improved GIQLI scores with minimal side effects in a selected cohort of patients and may be a safe alternative in the treatment of GERD.

Indexed as

Endoscopy, GastrointestinalFeasibility StudiesFemaleGastroesophageal RefluxHumansMaleManometryMiddle AgedPostoperative ComplicationsProspective StudiesQuality of LifeEndoscopic full-thickness plicationGERDQuality of lifeReflux activity

Identifiers

PMID29602998
PMCPMC5897467
OpenAlexW2795178685

What OpenQuestion holds

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Registered trials

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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.