NCT01910974

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

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, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

August 30, 2016

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

July 15, 2013

Last Update Submit

August 29, 2016

Conditions

Stomach NeoplasmIntestinal NeoplasmRectal Neoplasm

Keywords

oesophagusstomachintestinerectum

Outcome Measures

Primary Outcomes (1)

  • 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

    18 months

Study Arms (1)

endoscopic sub-mucosal dissection

EXPERIMENTAL
Procedure: endoscopic sub-mucosal dissection

Interventions

endoscopic sub-mucosal dissectionPROCEDURE

endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions

endoscopic sub-mucosal dissection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NESTIS

Lyon, Auvergne-Rhône-Alpes, 69437, France

Location

MeSH Terms

Conditions

Stomach NeoplasmsIntestinal NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal DiseasesColorectal NeoplasmsRectal Diseases

Study Officials

  • PINSET CHRISTIAN, CEO

    SPONSOR DIRECTOR

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Thieery Ponchon

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 30, 2013

Study Start

July 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

August 30, 2016

Record last verified: 2012-07

Locations

FR(1)