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
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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.
92 studies on the registry are indexed under Esophageal Diseases; 21 are open to participants now.
This study's enrollment of 4 is below the median of 50 across 66 interventional studies indexed under Esophageal Diseases.
Browse Esophageal Diseases studies →Erasme University Hospital is the lead sponsor of 181 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Mar 2018 to primary completion in Oct 2021, 43 months.
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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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