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

Free University of Brussels (ULB)

Status: Terminated

Conditions: Submucosal Tumor of Intestine

Treatments: Device: Endomina

Study type: Interventional

Funder types: Other

Identifiers

NCT03608540

P2018/263

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Device: Endomina