Endomina as an Aid for Endoscopic Full Thickness Resection

Submucosal Tumor of Intestine Clinical Trial

— EFTR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03608540
• Other study ID #: P2018/263
• Status: Terminated
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: October 25, 2021

Study information

• Verified date: November 2021
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Neoplasms
• Submucosal Tumor of Intestine

Intervention

Device:
• Endomina
Suturing system with sutures apposition then bulging then cutting

Locations

Country	Name	City	State
Belgium	Gastroenterology Department Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all Adverse Device Effects	Safety will be characterized by the incidence of all Adverse Device Effects	one year from procedure
Secondary	R0 resection	R0 resection at histology	1 month after resection