Traction Assisted Polypectomy of the Intestine | NCT00966420

Studies
Traction Assisted Polypectomy of the Intestine

NCT00966420

Sponsor

St John of God Hospital, Vienna

Status

Completed

Last Update Posted

Mar 30, 2010Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Colonic Polyps
Adenomatous Polyps

Interventions

traction assisted endoscopic mucosa resection

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 25, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2010

Last Update Posted Date

Mar 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mucosa resection	Experimental		Device: traction assisted endoscopic mucosa resection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
traction assisted endoscopic mucosa resection	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ablation of lesion in toto		1 week after intervention

Secondary Outcomes

Measure	Description	Time Frame
complications after resection		within one week after intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bernhard Dauser, MD	St John of God Hospital, Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Surgery, St John of God Hospital		Vienna	State of Vienna	1020	Austria

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps
D018256	Adenomatous Polyps

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided