Traction Assisted Polypectomy of the Intestine (TAEMR)

This study has been completed.
Sponsor:
Information provided by:
St John of God Hospital, Vienna
ClinicalTrials.gov Identifier:
NCT00966420
First received: August 25, 2009
Last updated: March 27, 2010
Last verified: March 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complications after resection [ Time Frame: within one week after intervention ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bernhard Dauser, MD, St John of God Hospital, Vienna
ClinicalTrials.gov Identifier: NCT00966420     History of Changes
Other Study ID Numbers: SJOG-01
Study First Received: August 25, 2009
Last Updated: March 27, 2010
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on April 17, 2014