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Traction Assisted Polypectomy of the Intestine

NCT ID: NCT00966420

Last Updated: 2010-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Colonic Polyps Adenomatous Polyps

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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mucosa resection

Group Type EXPERIMENTAL

traction assisted endoscopic mucosa resection

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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endoscopic polypectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St John of God Hospital, Vienna

OTHER

Sponsor Role lead

Responsible Party

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St John of God Hospital, Vienna

Principal Investigators

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Bernhard Dauser, MD

Role: PRINCIPAL_INVESTIGATOR

St John of God Hospital, Vienna

Locations

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Departement of Surgery, St John of God Hospital

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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SJOG-01

Identifier Type: -

Identifier Source: org_study_id