Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Stomach Neoplasms Clinical Trial

Official title:

Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01185483
• Other study ID #: ESD-HYBRID-AFDA
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2010
• Last updated: September 3, 2010
• Start date: November 2009
• Est. completion date: February 2011

Study information

• Verified date: August 2010
• Source: Odense University Hospital
• Contact: Michael H. Larsen, M.D.
• Phone: 0045 29694631
• Email: mhl[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Submucosal tumor (< 4 cm)

• Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion Criteria:

• Endoscopic ultrasound (EUS) or CT signs of metastasis

• Insufficient access to tumor

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endoscopy, Digestive System
• Esophageal Neoplasms
• Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark,