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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 September 2016 |
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Main ID: |
NCT01910974 |
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Date of registration:
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15/07/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multicentric Study an Endoscopic Treatment of Digestive Neoplasia by Submucosal Dissection Evaluation of a New Water Jet System
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Scientific title:
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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 |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01910974 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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PINSET CHRISTIAN, CEO |
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Address:
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Telephone:
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Email:
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Affiliation:
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SPONSOR DIRECTOR |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intestinal Neoplasm
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Rectal Neoplasm
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Stomach Neoplasm
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Intervention(s)
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Procedure: endoscopic sub-mucosal dissection
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Primary Outcome(s)
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SAFETY THAT IS TO SAY PERFORATION RATE AND delayed BLEEDING ONE
[Time Frame: 18 months]
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Secondary ID(s)
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TRESTIS
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TRESTIS 2013-A00133-42
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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