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Endomina Diverticulum

Primary Purpose

Oesophageal Disease

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Endomina
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oesophageal Disease focused on measuring endoscopy, mini invasive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gastroenterology Department Erasme Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dysphagia
Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia)

Full Information

First Posted
June 11, 2018
Last Updated
November 16, 2021
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03609073
Brief Title
Endomina Diverticulum
Official Title
A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Diverticulum Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
enrollment too slow
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Disease
Keywords
endoscopy, mini invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Endomina
Intervention Description
Suturing system then cutting the bridge between the diverticulum and the esophagus.
Primary Outcome Measure Information:
Title
Incidence of all Adverse Device Effects
Description
Safety will be characterized by the incidence of all Adverse Device Effects
Time Frame
one year from procedure
Secondary Outcome Measure Information:
Title
Dysphagia
Description
Efficacy will be measured by the Dakkak and Bennett score of Dysphagia (Score 0 - no dysphagia to 4 - aphagia)
Time Frame
one year from procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gastroenterology Department Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endomina Diverticulum

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