Colonoscopy Endoguide in Specialist Practice

This study has been completed.

Sponsor:

Collaborators:

A foundation of th Danish Association of Medical Specialists

Surgical Clinic, Allerød, Denmark

Information provided by (Responsible Party):

Lene Hendel, The Specialist Doctors at Rolighedsvej

ClinicalTrials.gov Identifier:

NCT01055782

First received: January 24, 2010

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Results First Received: March 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Conditions:	Colonoscopy Pain
Intervention:	Device: Endoguide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
With Endoguide	Colonoscopy completed with endoguide
Without Endoguide	Colonoscopy completed without endoguide

Participant Flow: Overall Study

	With Endoguide	Without Endoguide
STARTED	555	449
COMPLETED	555	449
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
With Endoguide	Colonoscopy completed with endoguide
Without Endoguide	Colonoscopy completed without endoguide
Total	Total of all reporting groups

Baseline Measures

	With Endoguide	Without Endoguide	Total
Number of Participants [units: participants]	555	449	1004
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	382	297	679
>=65 years	173	152	325
Age [units: years] Mean ± Standard Deviation	56 ± 14	56 ± 15	56 ± 15
Gender [units: participants]
Female	308	256	564
Male	247	193	440
Region of Enrollment [units: participants]
Denmark	555	449	1004

Outcome Measures

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1. Primary:

Completed Colonoscopy [ Time Frame: immediately after colonoscopy ]

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2. Secondary:

Perception of Pain [ Time Frame: After endoscopy (within 10mins) and 1 day after endoscopy ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
With Endoguide	Colonoscopy completed with endoguide
Without Endoguide	Colonoscopy completed without endoguide

Other Adverse Events

	With Endoguide	Without Endoguide
Total, other (not including serious) adverse events
# participants affected / at risk	0/555	0/449

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination due to higher than expected eligible patients

Results Point of Contact:

Name/Title: Lene Hendel MD
Organization: Specialist Doctors Rolighedsvej
phone: +4545819090
e-mail: lene@hendel.dk

No publications provided

Responsible Party:	Lene Hendel, The Specialist Doctors at Rolighedsvej
ClinicalTrials.gov Identifier:	NCT01055782 History of Changes
Other Study ID Numbers:	H-1-2009-80
Study First Received:	January 24, 2010
Results First Received:	March 23, 2012
Last Updated:	June 6, 2012
Health Authority:	Denmark: Danish Dataprotection Agency Denmark: The Regional Committee on Biomedical Research Ethics

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