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Traction Assisted Polypectomy of the Intestine (TAEMR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966420
First Posted: August 27, 2009
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
St John of God Hospital, Vienna
  Purpose
The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.

Condition Intervention
Colonic Polyps Adenomatous Polyps Device: traction assisted endoscopic mucosa resection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traction Assisted Endoscopic Mucosa Resection (TAEMR)

Resource links provided by NLM:


Further study details as provided by St John of God Hospital, Vienna:

Primary Outcome Measures:
  • ablation of lesion in toto [ Time Frame: 1 week after intervention ]

Secondary Outcome Measures:
  • complications after resection [ Time Frame: within one week after intervention ]

Enrollment: 7
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: mucosa resection Device: traction assisted endoscopic mucosa resection
A haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop.
Other Name: endoscopic polypectomy

Detailed Description:

We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique.

The traction will be performed by using a haemoclip connected to surgical suture materials. The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection.

The aim of the study is to show the feasibility of this technique.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • benign lesions in the large and small intestine
  • diameter of lesion smaller than 3cm

Exclusion Criteria:

  • malign lesions of the large and small intestine
  • diameter of lesions larger than 3cm
  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): NCT00966420


Locations
Austria
Departement of Surgery, St John of God Hospital
Vienna, Austria, 1020
Sponsors and Collaborators
St John of God Hospital, Vienna
Investigators
Principal Investigator: Bernhard Dauser, MD St John of God Hospital, Vienna
  More Information

Responsible Party: Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT00966420     History of Changes
Other Study ID Numbers: SJOG-01
First Submitted: August 25, 2009
First Posted: August 27, 2009
Last Update Posted: March 30, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Adenomatous Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms