Endomina as an Aid for Endoscopic Full Thickness Resection

NCT ID: NCT03608540

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-09
• Study Completion Date: 2021-10-25

Brief 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.

Conditions

Submucosal Tumor of Intestine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Suturing system with suture apposition then bulging formation then cutting the lesion

Group Type: EXPERIMENTAL

Endomina

Intervention Type: DEVICE

Suturing system with sutures apposition then bulging then cutting

Interventions

Endomina

Suturing system with sutures apposition then bulging then cutting

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterology Department Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

P2018/263

Identifier Type: -

Identifier Source: org_study_id