A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Diverticulum Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Incidence of all Adverse Device Effects
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Incidence of all Adverse Device Effects
Time Frame: one year from procedure
Safety will be characterized by the incidence of all Adverse Device Effects
Secondary Outcomes
- Dysphagia(one year from procedure)