An interventional study of Endomina in Oesophageal Disease, sponsored by Erasme University Hospital. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-11-24.
Sponsored by Erasme University Hospital · Not applicable, Interventional, and Treatment
Esophageal diverticulum is a rare disease. Majority comes form the pharyngo-esophageal junction (70 % Zenker's Diverticulum), 10% are mediothoracic and 20% epiphrenic. Zenker's diverticulum is well treated with endoscopy (efficacy around 80%, complications around 5%) (1). For medio or epihrenic diverticulum, the classic treatment is surgery (diverticulectomy with or without anti-reflux surgery) but is associated with 33% morbidity and 9% mortality (2). Recently another technique involving magnet was described (3). Five patients were treated with success.
Considering the surgical risk, other techniques need to be evaluated. Using the Endomina device, sutures can be apposed between the foot of the diverticulum and the esophageal lumen. If necessary the bridge between the diverticulum and the esophagus can be cut with needle knife as described in Zenker's diverticulum treatment.
Exclusion Criteria:
Device: Endomina
Suturing system then cutting the bridge between the diverticulum and the esophagus.
Incidence of all Adverse Device Effects
Safety will be characterized by the incidence of all Adverse Device Effects
Time frame: one year from procedure
Dysphagia
Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia)
Time frame: one year from procedure
Plan to share: No
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This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Erasme University Hospital