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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
Sponsor:
Information provided by:

Study Description
Brief 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.


Condition or disease
Endoscopy, Digestive System Esophageal Neoplasms Stomach Neoplasms

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Responsible Party: Michael Bau Mortensen, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01185483     History of Changes
Other Study ID Numbers: ESD-HYBRID-AFDA
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: August 2010

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

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