Endomina as an Aid for Endoscopic Full Thickness Resection

NCT03608540 | Terminated DMC

• 1 other identifier: P2018/263
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of all Adverse Device Effects

  Safety will be characterized by the incidence of all Adverse Device Effects

  one year from procedure

Secondary Outcomes (1)

• R0 resection

  1 month after resection

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: Endomina

Interventions

Endomina DEVICE

Suturing system with sutures apposition then bulging then cutting

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Gastroenterology Department Erasme Hospital

Brussels, 1070, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 1, 2018
• Study Start: July 9, 2018
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)