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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014