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

Primary Purpose

Stomach Neoplasm, Intestinal Neoplasm, Rectal Neoplasm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endoscopic sub-mucosal dissection
Sponsored by
Hôpital Edouard Herriot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring oesophagus, stomach, intestine, rectum

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NESTIS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endoscopic sub-mucosal dissection

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2013
Last Updated
August 29, 2016
Sponsor
Hôpital Edouard Herriot
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1. Study Identification

Unique Protocol Identification Number
NCT01910974
Brief Title
Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Edouard Herriot

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm, Intestinal Neoplasm, Rectal Neoplasm
Keywords
oesophagus, stomach, intestine, rectum

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
endoscopic sub-mucosal dissection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
endoscopic sub-mucosal dissection
Intervention Description
endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions
Primary Outcome Measure Information:
Title
SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
Description
inclusion duration is about 6 months the following period will be about 12 months so a total duration of 18 months
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PINSET CHRISTIAN, CEO
Organizational Affiliation
SPONSOR DIRECTOR
Official's Role
Study Director
Facility Information:
Facility Name
NESTIS
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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