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| ID | Type | Description | Link |
|---|---|---|---|
| TRESTIS | Other Identifier | RCB 2013-A00133-42 |
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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).
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic sub-mucosal dissection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic sub-mucosal dissection | Procedure | endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PINSET CHRISTIAN, CEO | SPONSOR DIRECTOR | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NESTIS | Lyon | Auvergne-Rhône-Alpes | 69437 | France |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D007414 | Intestinal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007410 | Intestinal Diseases |
| D015179 | Colorectal Neoplasms |
| D012002 | Rectal Diseases |
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