Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

September 3, 2010 updated by: Odense University Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael H. Larsen, M.D.
  • Phone Number: 0045 29694631
  • Email: mhl@dadlnet.dk

Study Locations

  • Denmark
      • Odense, Denmark, 5250
        • Recruiting
        • Odense University Hospital
        • Contact:
          • Michael H Larsen, M.D.
          • Phone Number: 0045 29694631
          • Email: mhl@dadlnet.dk
        • Sub-Investigator:
          • Michael B. Mortensen, M.D., Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESD-HYBRID-AFDA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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