Endomina Diverticulum

Not Applicable

Terminated

• Conditions: Oesophageal Disease
• Interventions: Device: Endomina

• Registration Number: NCT03609073
• Lead Sponsor: Erasme University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-06-11
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-08-01
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1. Symptomatic medio or epiphrenic diverticulum.
2. Age between 18-80 years;
3. 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;
4. Must be able to understand and be willing to provide written informed consent;
5. Must live within 75 km of the treatment site;

Exclusion Criteria

1. Achalasia and any other esophageal motility disorders.
2. Severe esophagitis
3. Gastro-duodenal ulcer
4. Severe renal, hepatic, pulmonary disease or cancer;
5. GI stenosis or obstruction;
6. Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months;
7. Anticoagulant therapy;
8. Currently participating in other study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Endomina	-

Primary Outcome Measures

Name	Time	Method
Incidence of all Adverse Device Effects	one year from procedure	Safety will be characterized by the incidence of all Adverse Device Effects

Secondary Outcome Measures

Name	Time	Method
Dysphagia	one year from procedure	Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia)

Trial Locations

Locations (1)

Gastroenterology Department Erasme Hospital; 🇧🇪 Brussels, Belgium