Rétrospective Evaluation of the Performance and the Safet... | NCT03467451

Studies
Rétrospective Evaluation of the Performance and the Safety of the Endoscopic Mucosectomy With Anchorage

NCT03467451

Sponsor

Hôpital Edouard Herriot

Status

Completed

Last Update Posted

Mar 19, 2018Actual

Enrollment

125Actual

Phase

Not provided

Conditions

Polyps of Colon

Interventions

Endoscopic Mucosectomy

Countries

Not provided

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jul 1, 2016Actual

Completion Date

Jan 1, 2018Actual

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 9, 2018

First Posted Date

Mar 16, 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

Mar 15, 2018

Last Update Posted Date

Mar 19, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean Christophe Saurin, Professor, Société Française d'Endoscopie DigestivePrincipal Investigator

Lead Sponsor

Hôpital Edouard HerriotOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This safe and simple technique without extra cost would allow us to improve R0 resection ratio and so decrease relapses and the time between two different exams

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Mucosectomy	Procedure	Endoscopic Mucosectomy with anchorage of the tip of the loop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18 years old
Other rectal or colic résections from 10 to 30 mm into the past

Exclusion Criteria:

Colitis, Crohn Disease or Ulcerative Colitis
Intense fibrosis under the lesion

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Both male and female over 18 years old with other rectal or colic résections from 10 to 30 mm into the past

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mathieu Pioche	Hôpital Edouard Herriot	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided