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

Primary Purpose

Submucosal Tumor of Intestine

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Endomina
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Submucosal Tumor of Intestine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gastroenterology Department Erasme Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

R0 resection
R0 resection at histology

Full Information

First Posted
July 10, 2018
Last Updated
November 16, 2021
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03608540
Brief Title
Endomina as an Aid for Endoscopic Full Thickness Resection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Enrolment too slow
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submucosal Tumor of Intestine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Suturing system with suture apposition then bulging formation then cutting the lesion
Intervention Type
Device
Intervention Name(s)
Endomina
Intervention Description
Suturing system with sutures apposition then bulging then cutting
Primary Outcome Measure Information:
Title
Incidence of all Adverse Device Effects
Description
Safety will be characterized by the incidence of all Adverse Device Effects
Time Frame
one year from procedure
Secondary Outcome Measure Information:
Title
R0 resection
Description
R0 resection at histology
Time Frame
1 month after resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gastroenterology Department Erasme Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Endomina as an Aid for Endoscopic Full Thickness Resection

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