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Completed

NCT Number: NCT01910974

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

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).

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Key information

Conditions

Stomach Neoplasm Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasm Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasm Rectal Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NESTIS

Lyon, Auvergne-Rhône-Alpes, 69437, France

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic sub-mucosal dissection

Procedure

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hôpital Edouard Herriot

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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