Trial Outcomes & Findings for Efficacy of the Third Eye Retroscope Auxiliary Imaging System (NCT NCT00657371)

Results Overview

After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

288 participants

Primary outcome timeframe

Total 30 minutes procedure time with TER use.

Results posted on

2013-12-09

Participant Flow

Recruitment Period: March 05, 2008 to May 16, 2010 with recruitment completed in medical settings including university medical centers, ambulatory surgery centers, a community medical center and a physician's office.

Participant milestones

Participant milestones
Measure	Third Eye Retroscope Colonoscopy exam using the Third Eye Retroscope device
Overall Study STARTED	288
Overall Study COMPLETED	249
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Third Eye Retroscope Colonoscopy exam using the Third Eye Retroscope device
Overall Study Poor bowel preparation	15
Overall Study Unable to intubate the cecum	5
Overall Study Protocol Violation	2
Overall Study Device- related reasons	13
Overall Study Pre-existing medical condition	4

Baseline Characteristics

Efficacy of the Third Eye Retroscope Auxiliary Imaging System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Third Eye Retroscope n=288 Participants Colonoscopy exam using the Third Eye Retroscope device
Age Continuous	63 years FULL_RANGE 6.5 • n=5 Participants
Sex: Female, Male Female	156 Participants n=5 Participants
Sex: Female, Male Male	132 Participants n=5 Participants
Region of Enrollment United States	288 participants n=5 Participants

PRIMARY outcome

Timeframe: Total 30 minutes procedure time with TER use.

After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.

Outcome measures

Outcome measures
Measure	Third Eye Retroscope n=257 Polyps Colonoscopy exam using the Third Eye Retroscope device
Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER)	13.2 percent of polyps

PRIMARY outcome

Timeframe: Total 30 minutes procedure time with TER use.

Population: Those polyps reported for Third Eye Retroscope were additional, located behind folds and then found with the colonscope only because they were first detected with the Third Eye Retroscope.

After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.

Outcome measures

Outcome measures
Measure	Third Eye Retroscope n=257 Polyps Colonoscopy exam using the Third Eye Retroscope device
Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) Standard Colonoscope (Total)	257 polyps
Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) Third Eye Retroscope	34 polyps

SECONDARY outcome

Timeframe: 2 year study period to collect colonoscopy exam results

Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.

Outcome measures

Outcome data not reported

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

Robert S. Bresalier, MD / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place