Endomina as an Aid for Endoscopic Full Thickness Resection (EFTR)

A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Full Thickness Resection

The concept of natural orifice transluminal endoscopic surgery (NOTES) (1) has evolved to endoscopic full thickness resection (EFTR). It represents innovation in technique that allows endoscopists to advance further into the endoscopic surgical space. EFTR has transformed the ability to tackle subepithelial tumors (SETs) and early mucosal neoplasm that are not amenable to classic ESD technique, enhance the staging accuracies for marginal lesions, and even increase the diagnostic capabilities for infiltrative disorders. Thus far, multiple methods have been described to perform EFTR, including nonexposed and exposed techniques, with the closure occuring before resection or after resection, respectively (2). Early comparative studies show no difference between the two methods (3). However, the procedures themselves are limited by the current tools available and by described techniques to achieve resection.

Investigators are described here a novel non-exposed technique, with closure before resection, using the Endomina device.

Study Overview

• Status: Terminated
• Conditions: Submucosal Tumor of Intestine
• Intervention / Treatment: Device: Endomina

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Gastroenterology Department Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Lesion untreatable with standard technique.
2. Age between 18-65 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 (for upper GI lesion)
2. Severe esophagitis (for upper GI lesion)
3. Gastro-duodenal ulcer (for upper GI lesion)
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. Impending gastric surgery 60 days post intervention (Upper GI);
9. Currently participating in other study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Suturing system with suture apposition then bulging formation then cutting the lesion	Device: Endomina; Suturing system with sutures apposition then bulging then cutting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all Adverse Device Effects	Safety will be characterized by the incidence of all Adverse Device Effects	one year from procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection	R0 resection at histology	1 month after resection

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms
• Other Study ID Numbers: P2018/263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No