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Endomina Diverticulum

Sponsor
Erasme University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03609073
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
43.7
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Endomina
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Diverticulum Treatment
Actual Study Start Date :
Mar 6, 2018
Actual Primary Completion Date :
Oct 25, 2021
Actual Study Completion Date :
Oct 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Dysphagia [one year from procedure]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gastroenterology Department Erasme Hospital Brussels Belgium 1070

Sponsors and Collaborators

  • Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erasme University Hospital
ClinicalTrials.gov Identifier:
NCT03609073
Other Study ID Numbers:
  • P2018/262
First Posted:
Aug 1, 2018
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erasme University Hospital
endoscopy
mini invasive
Additional relevant MeSH terms:
Diverticulum
Esophageal Diseases

Study Results

No Results Posted as of Nov 24, 2021