NCT03467451

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1 year

First QC Date

March 9, 2018

Last Update Submit

March 15, 2018

Conditions

Polyps of Colon

Outcome Measures

Primary Outcomes (1)

  • Measure the proportion of R0 resections of anchored mucosectomies from 10 to 30 mm colon and rectum lesions

    One year

Interventions

Endoscopic MucosectomyPROCEDURE

Endoscopic Mucosectomy with anchorage of the tip of the loop

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mathieu Pioche

    Hôpital Edouard Herriot

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 16, 2018

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

January 1, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03