Endomina as an Aid for Endoscopic Full Thickness Resection | NCT03608540

Studies
Endomina as an Aid for Endoscopic Full Thickness Resection

NCT03608540

Sponsor

Erasme University Hospital

Status

Terminated

Last Update Posted

Nov 24, 2021Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Submucosal Tumor of Intestine

Interventions

Endomina

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrolment too slow

Expanded Access Info

Start Date

Jul 9, 2018Actual

Primary Completion Date

Oct 25, 2021Actual

Completion Date

Oct 25, 2021Actual

First Submitted Date

Jul 10, 2018

First Submission Date that Met QC Criteria

Jul 31, 2018

First Posted Date

Aug 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2021

Last Update Posted Date

Nov 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Suturing system with suture apposition then bulging formation then cutting the lesion	Device: Endomina

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endomina	Device	Suturing system with sutures apposition then bulging then cutting	Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
R0 resection	R0 resection at histology	1 month after resection

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Department Erasme Hospital		Brussels		1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided