Traction Assisted Polypectomy of the Intestine (TAEMR)

March 27, 2010 updated by: St John of God Hospital, Vienna

Traction Assisted Endoscopic Mucosa Resection (TAEMR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Austria
      • Vienna, Austria, 1020
        • Departement of Surgery, St John of God Hospital

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • endoscopic polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ablation of lesion in toto
Time Frame: 1 week after intervention
1 week after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
complications after resection
Time Frame: within one week after intervention
within one week after intervention

Collaborators and Investigators

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

Sponsor

St John of God Hospital, Vienna

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

July 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 30, 2010

Last Update Submitted That Met QC Criteria

March 27, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJOG-01

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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