Endomina Diverticulum

NCT03609073 | Terminated DMC

• 1 other identifier: P2018/262
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Disease

Keywords

endoscopy; mini invasive

Outcome Measures

Primary Outcomes (1)

• Incidence of all Adverse Device Effects

  Safety will be characterized by the incidence of all Adverse Device Effects

  one year from procedure

Secondary Outcomes (1)

• Dysphagia

  one year from procedure

Study Arms (1)

Intervention

EXPERIMENTAL

Device: Endomina

Interventions

Endomina DEVICE

Suturing system then cutting the bridge between the diverticulum and the esophagus.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: August 1, 2018
• Study Start: March 6, 2018
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)