NCT00966420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

8 months

First QC Date

August 25, 2009

Last Update Submit

March 27, 2010

Conditions

Colonic PolypsAdenomatous Polyps

Outcome Measures

Primary Outcomes (1)

  • ablation of lesion in toto

    1 week after intervention

Secondary Outcomes (1)

  • complications after resection

    within one week after intervention

Study Arms (1)

mucosa resection

EXPERIMENTAL
Device: traction assisted endoscopic mucosa resection

Interventions

traction assisted endoscopic mucosa resectionDEVICE

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.

Also known as: endoscopic polypectomy
mucosa resection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • benign lesions in the large and small intestine
  • diameter of lesion smaller than 3cm

You may not qualify if:

  • malign lesions of the large and small intestine
  • diameter of lesions larger than 3cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Surgery, St John of God Hospital

Vienna, Vienna, 1020, Austria

Location

MeSH Terms

Conditions

Colonic PolypsAdenomatous Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Bernhard Dauser, MD

    St John of God Hospital, Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 27, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

AU(1)