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NCT00966420 Clinical Trial

Traction Assisted Polypectomy of the Intestine

Colonic Polyps Clinical Trial

— TAEMR  

Official title:
Traction Assisted Endoscopic Mucosa Resection (TAEMR)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00966420
Other study ID # SJOG-01
Secondary ID
Status Completed
Phase N/A
First received August 25, 2009
Last updated March 27, 2010
Start date July 2009
Est. completion date March 2010

Study information
Verified date March 2010
Source St John of God Hospital, Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Austria Departement of Surgery, St John of God Hospital Vienna

Sponsors (1)
Lead Sponsor Collaborator
St John of God Hospital, Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary ablation of lesion in toto 1 week after intervention Yes
Secondary complications after resection within one week after intervention Yes
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