Trial Outcomes & Findings for Impact of Experience on Results With the Third Eye Retroscope (NCT NCT00969124)

NCT ID: NCT00969124

Last Updated: 2017-07-26

Results Overview

Adenomas detected with the colonoscope alone vs. with the Retroscope

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 328 participants
• Primary outcome timeframe: During the colonoscopy procedure (up to 1 hour, average 25 minutes)
• Results posted on: 2017-07-26

Participant Flow

Participant milestones

Measure	Third Eye Retroscope All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Overall Study STARTED	328
Overall Study COMPLETED	298
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	Third Eye Retroscope All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Overall Study Protocol Violation	2
Overall Study Inadequate bowel preparation	15
Overall Study Inability to reach cecum	9
Overall Study Previously unrecognized disease	3
Overall Study Technical error	1

Baseline Characteristics

Impact of Experience on Results With the Third Eye Retroscope

Baseline characteristics by cohort

Measure	Third Eye Retroscope n=298 Participants All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Age, Continuous	56.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	154 Participants n=5 Participants
Sex: Female, Male Male	144 Participants n=5 Participants
Region of Enrollment United States	298 participants n=5 Participants
Indication for colonoscopy procedure (screening, surveillance or diagnostic) Screening	164 participants n=5 Participants
Indication for colonoscopy procedure (screening, surveillance or diagnostic) Surveillance	62 participants n=5 Participants
Indication for colonoscopy procedure (screening, surveillance or diagnostic) Diagnostic	72 participants n=5 Participants

PRIMARY outcome

Timeframe: During the colonoscopy procedure (up to 1 hour, average 25 minutes)

Adenomas detected with the colonoscope alone vs. with the Retroscope

Outcome measures

Measure	Third Eye Retroscope n=298 Participants All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Detection Rates for Adenomas Adenomas detected with colonoscope alone	100 Adenomas
Detection Rates for Adenomas Additional adenomas detected with Retroscope	16 Adenomas

PRIMARY outcome

Timeframe: During the colonoscopy procedure (up to 1 hour, average 25 minutes)

All polyps detected with the colonoscope alone vs. with the Retroscope

Outcome measures

Measure	Third Eye Retroscope n=298 Participants All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Detection Rates for All Polyps All polyps detected with colonoscope alone	182 All polyps
Detection Rates for All Polyps Additional all polyps detected with Retroscope	27 All polyps

SECONDARY outcome

Timeframe: During the colonoscopy procedure (up to 1 hour, average 25 minutes)

Time in minutes for withdrawal phase of procedure and for total procedure

Outcome measures

Measure	Third Eye Retroscope n=298 Participants All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Time Spent During Withdrawal Phase and Total Procedure Average withdrawal time	9.9 minutes Standard Deviation 4.1
Time Spent During Withdrawal Phase and Total Procedure Average total procedure time	24.7 minutes Standard Deviation 9.7

Adverse Events

Third Eye Retroscope

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

Jack Higgins, MD - Chief Medical Officer

Avantis Medical Systems , Inc.

Phone: 4086367226

Email: jhiggins@avantismedical.com

Results disclosure agreements

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