NCT01185483

Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Endoscopy, Digestive System
• Esophageal Neoplasms
• Stomach Neoplasms

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-11-01
• Completion: 2011-02-01
• First posted: 2010-08-20
• Last updated: 2010-09-06

Locations

1 site across 1 country: Denmark