Trial Outcomes & Findings for Colonoscopy Endoguide in Specialist Practice (NCT NCT01055782)

NCT ID: NCT01055782

Last Updated: 2012-06-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1004 participants
• Primary outcome timeframe: immediately after colonoscopy
• Results posted on: 2012-06-11

Participant Flow

Participant milestones

Measure	With Endoguide Colonoscopy completed with endoguide	Without Endoguide Colonoscopy completed without endoguide
Overall Study STARTED	555	449
Overall Study COMPLETED	555	449
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colonoscopy Endoguide in Specialist Practice

Baseline characteristics by cohort

Measure	With Endoguide n=555 Participants Colonoscopy completed with endoguide	Without Endoguide n=449 Participants Colonoscopy completed without endoguide	Total n=1004 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	382 Participants n=5 Participants	297 Participants n=7 Participants	679 Participants n=5 Participants
Age, Categorical >=65 years	173 Participants n=5 Participants	152 Participants n=7 Participants	325 Participants n=5 Participants
Age Continuous	56 years STANDARD_DEVIATION 14 • n=5 Participants	56 years STANDARD_DEVIATION 15 • n=7 Participants	56 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	308 Participants n=5 Participants	256 Participants n=7 Participants	564 Participants n=5 Participants
Sex: Female, Male Male	247 Participants n=5 Participants	193 Participants n=7 Participants	440 Participants n=5 Participants
Region of Enrollment Denmark	555 participants n=5 Participants	449 participants n=7 Participants	1004 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately after colonoscopy

Population: Choosen by randomization.

Outcome measures

Measure	With Endoguide - Success Rate n=555 Participants Exams completed with endoguide. Success rate/completion.	Without Endoguide n=449 Participants Exams completed without endoguide. Success rate/completion.
Completed Colonoscopy	555 participants	449 participants

SECONDARY outcome

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

VAS (Visual Analogue Scale), 0 - 10. VAS 0 is no pain, VAS 10 is max pain. Scores on a scale

Outcome measures

Measure	With Endoguide - Success Rate n=555 Participants Exams completed with endoguide. Success rate/completion.	Without Endoguide n=449 Participants Exams completed without endoguide. Success rate/completion.
Perception of Pain Score within 10mins of endoscopy	3.84 Scores on a scale 0-10 Standard Deviation 2.78	4.12 Scores on a scale 0-10 Standard Deviation 2.98
Perception of Pain Score 1 day after endoscopy	3.56 Scores on a scale 0-10 Standard Deviation 2.90	3.72 Scores on a scale 0-10 Standard Deviation 3.15

Adverse Events

With Endoguide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Without Endoguide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lene Hendel MD

Specialist Doctors Rolighedsvej

Phone: +4545819090

Email: lene@hendel.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place