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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01185483
Other study ID # ESD-HYBRID-AFDA
Secondary ID
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


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, 

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