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Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01185483
First received: August 17, 2010
Last updated: September 3, 2010
Last verified: August 2010
History of Changes
  Purpose

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
Endoscopy, Digestive System
Esophageal Neoplasms
Stomach Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients referred to the Endoscopic Section at the Department of Surgery, Odense University Hospital, with a mucosal or submucosal tumor in the esophagus or stomach.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185483

Contacts
Contact: Michael H. Larsen, M.D. 0045 29694631 mhl@dadlnet.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5250
Contact: Michael H Larsen, M.D.     0045 29694631     mhl@dadlnet.dk    
Sub-Investigator: Michael B. Mortensen, M.D., Phd            
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Michael Bau Mortensen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01185483     History of Changes
Other Study ID Numbers: ESD-HYBRID-AFDA
Study First Received: August 17, 2010
Last Updated: September 3, 2010
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Endoscopic submucosal dissection
Submucosal tumor
Minimal invasive
Gastroscopy

Additional relevant MeSH terms:
Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Stomach Diseases

ClinicalTrials.gov processed this record on June 13, 2013