Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife
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|ClinicalTrials.gov Identifier: NCT01185483|
Recruitment Status : Unknown
Verified August 2010 by Odense University Hospital.
Recruitment status was: Recruiting
First Posted : August 20, 2010
Last Update Posted : September 6, 2010
Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.
New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.
The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.
|Condition or disease|
|Endoscopy, Digestive System Esophageal Neoplasms Stomach Neoplasms|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||February 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185483
|Contact: Michael H. Larsen, M.D.||0045 firstname.lastname@example.org|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5250|
|Contact: Michael H Larsen, M.D. 0045 29694631 email@example.com|
|Sub-Investigator: Michael B. Mortensen, M.D., Phd|