Back to resultsTraction Assisted Polypectomy of the Intestine (TAEMR)
Primary Purpose
Colonic Polyps, Adenomatous Polyps
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
traction assisted endoscopic mucosa resection
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Polyps
Eligibility 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
Sites / Locations
- Departement of Surgery, St John of God Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mucosa resection
Arm Description
Outcomes
Primary Outcome Measures
ablation of lesion in toto
Secondary Outcome Measures
complications after resection
Full Information
NCT ID
NCT00966420
First Posted
August 25, 2009
Last Updated
March 27, 2010
Sponsor
St John of God Hospital, Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00966420
Brief Title
Traction Assisted Polypectomy of the Intestine
Acronym
TAEMR
Official Title
Traction Assisted Endoscopic Mucosa Resection (TAEMR)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
St John of God Hospital, Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Adenomatous Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mucosa resection
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
traction assisted endoscopic mucosa resection
Other Intervention Name(s)
endoscopic polypectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
ablation of lesion in toto
Time Frame
1 week after intervention
Secondary Outcome Measure Information:
Title
complications after resection
Time Frame
within one week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard Dauser, MD
Organizational Affiliation
St John of God Hospital, Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Surgery, St John of God Hospital
City
Vienna
ZIP/Postal Code
1020
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Traction Assisted Polypectomy of the Intestine
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