Endomina as an Aid for Endoscopic Full Thickness Resection

Study Overview
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Brief Summary
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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.

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

Conditions
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Submucosal Tumor of Intestine

Intervention / Treatment
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* Device: Endomina


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Lesion untreatable with standard technique. Age between 18-65 years; 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; Must be able to understand and be willing to provide written informed consent; Must live within 75 km of the treatment site; Exclusion Criteria: Achalasia and any other esophageal motility disorders (for upper GI lesion) Severe esophagitis (for upper GI lesion) Gastro-duodenal ulcer (for upper GI lesion) Severe renal, hepatic, pulmonary disease or cancer; GI stenosis or obstruction; Pregnancy, breastfeeding or willing to become pregnant in the coming 18 months; Anticoagulant therapy; Impending gastric surgery 60 days post intervention (Upper GI); Currently participating in other study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Suturing system with suture apposition then bulging formation then cutting the lesion | Device: Endomina<br>* Suturing system with sutures apposition then bulging then cutting<br>|

What is the study measuring?
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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 |