Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System

August 29, 2016 updated by: Jean Christophe Saurin, Hôpital Edouard Herriot

TRESTIS: Multicentric Study With a Curative Endoscopic Treatment of Superficial Neoplasia of a Digestive Tract by Endoscopic Submucosal Dissection: Evaluation of a New Water Jet System Injecting Glycerol Mix

safety evaluation of endoscopic sub-mucosal dissection with nestis enki2 system. This system is a new water jet system which allows to perform Endoscopic submucosal dissection with a bifunctional catheter (injection and cutting).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evaluation of the ability of this system to have a complete resection of superficial tumors of the digestive tract (that is to say a resection with free lateral and deep margins without residual tumor tissue)

Evaluation of the ability of such system to inject a viscous macromolecular solution of glycerol (glycerol mix: Glycerol 10 %, Fructose 5 %, saline solution 0.9%)(27. Fujishiro M, Yahagi N, Kashimura K, et al. Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection. Endoscopy. 2004;36:579-583.)

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone Alpes
      • Lyon, Rhone Alpes, France, 69437
        • NESTIS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OVER 18 YEARS OLD
  • PATIENTS AGREED WITH THE STUDY
  • SCORE ASA 1 OR 2
  • Patient recorded in a social safety organism
  • patients presenting with superficial lesions with an endoscopic indication of resection

Exclusion Criteria:

  • under 18 years old
  • Patients not agreed with the study
  • pregnant women
  • patient included in an another study
  • medical treatments (radiotherapy, surgery endoscopis treatements) before the intervention
  • coagulation disorders
  • score asa over 3
  • patients with another neoplasic lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: endoscopic sub-mucosal dissection
Procedure: endoscopic sub-mucosal dissection
endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
Time Frame: 18 months
inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Edouard Herriot

Investigators

  • Study Director: PINSET CHRISTIAN, CEO, SPONSOR DIRECTOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (ESTIMATE)

July 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRESTIS 2013-A00133-42
  • TRESTIS (OTHER: RCB 2013-A00133-42)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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