Endomina Diverticulum

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Diverticulum Treatment

Conditions
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Oesophageal Disease

Intervention / Treatment
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* Device: Endomina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic medio or epiphrenic diverticulum. Age between 18-80 years; Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment, endoscopy, radiography, as well as laboratory investigations; Must be able to understand and be willing to provide written informed consent; Must live within 75 km of the treatment site; Exclusion Criteria: Achalasia and any other esophageal motility disorders. Severe esophagitis Gastro-duodenal ulcer Severe renal, hepatic, pulmonary disease or cancer; GI stenosis or obstruction; Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months; Anticoagulant therapy; Currently participating in other study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Device: Endomina<br>* Suturing system then cutting the bridge between the diverticulum and the esophagus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all Adverse Device Effects | Safety will be characterized by the incidence of all Adverse Device Effects | one year from procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia | Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia) | one year from procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopy, mini invasive