NCT01055782

Brief Summary

The study includes 700 patients referred for colonoscopy are randomized to colonoscopy with or without endoguide. The study will investigate whether the endoguide improves success rate and the patient's perception of pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,004

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration 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

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 28, 2012

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

1.4 years

First QC Date

January 24, 2010

Results QC Date

March 23, 2012

Last Update Submit

June 6, 2012

Conditions

ColonoscopyPain

Keywords

ColonoscopyEndoguidePain perceptionColonoscopy to the coecum (success rate)Patient's perception of painDuration of successful colonoscopies

Outcome Measures

Primary Outcomes (1)

  • Completed Colonoscopy

    immediately after colonoscopy

Secondary Outcomes (1)

  • Perception of Pain

    After endoscopy (within 10mins) and 1 day after endoscopy

Study Arms (2)

With endoguide

EXPERIMENTAL

Colonoscopy completed with endoguide

Device: Endoguide

Without endoguide

NO INTERVENTION

Colonoscopy completed without endoguide

Interventions

EndoguideDEVICE

Use of endoguide to facilitate completion of endoscopy

With endoguide

Eligibility Criteria

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

You may qualify if:

  • Informed consent provided

You may not qualify if:

  • Informed consent not provided or not possible to obtain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Speciallægerne på Rolighedsvej

Birkerød, Birkerød, 3460, Denmark

Location

Related Publications (1)

  • Bak-Christensen A, Knudsen E, Hendel J, Ifaoui IB, Lehrskov-Schmidt L, Hendel L. Colonoscopy results are not enhanced by use of magnet endoguide in specialist practice. Dan Med J. 2013 Jun;60(6):A4611.

    PMID: 23743108DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to higher than expected eligible patients

Results Point of Contact

Title
Lene Hendel MD
Organization
Specialist Doctors Rolighedsvej
lene@hendel.dk
+4545819090

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMsc

Study Record Dates

First Submitted

January 24, 2010

First Posted

January 26, 2010

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

June 1, 2012

Last Updated

June 11, 2012

Results First Posted

May 28, 2012

Record last verified: 2012-06

Locations

DK(1)