Endomina Diverticulum

Oesophageal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03609073
• Other study ID #: P2018/262
• Status: Terminated
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: October 25, 2021

Study information

• Verified date: November 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulum
• Esophageal Diseases
• Oesophageal Disease

Intervention

Device:
• Endomina
Suturing system then cutting the bridge between the diverticulum and the esophagus.

Locations

Country	Name	City	State
Belgium	Gastroenterology Department Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all Adverse Device Effects	Safety will be characterized by the incidence of all Adverse Device Effects	one year from procedure
Secondary	Dysphagia	Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia)	one year from procedure