Trial Outcomes & Findings for I-scan for Adenoma Detection (NCT NCT02811419)

NCT ID: NCT02811419

Last Updated: 2019-05-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 740 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-05-01

Participant Flow

Participant milestones

Measure	Intervention (I-scan) i-scan 1 (surface enhancement with contrast enhancement)	Control (HDWL) HDWL (High definition white light)
Overall Study STARTED	369	371
Overall Study COMPLETED	357	358
Overall Study NOT COMPLETED	12	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

I-scan for Adenoma Detection

Baseline characteristics by cohort

Measure	I-scan n=369 Participants Inspection with i-scan surface enhancement i-scan: examination will be performed with i-scan digital enhancement	Standard High-definition White Light n=371 Participants Inspection with standard high-definition white light (usual care) standard high-definition white light: examination will be performed with high-definition white light	Total n=740 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 7.5 • n=5 Participants	60.8 years STANDARD_DEVIATION 7.5 • n=7 Participants	61.1 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	185 Participants n=5 Participants	187 Participants n=7 Participants	372 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants	184 Participants n=7 Participants	368 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	369 Participants n=5 Participants	371 Participants n=7 Participants	740 Participants n=5 Participants
Region of Enrollment United States	369 participants n=5 Participants	371 participants n=7 Participants	740 participants n=5 Participants
body mass index	27.0 kg/m^2 STANDARD_DEVIATION 5.7 • n=5 Participants	26.5 kg/m^2 STANDARD_DEVIATION 4.9 • n=7 Participants	26.7 kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Intervention (I-scan) n=369 Participants i-scan 1 (surface enhancement with contrast enhancement)	Control (HDWL) n=371 Participants HDWL (High definition white light)
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected	208 Participants	171 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	Intervention (I-scan) n=369 Participants i-scan 1 (surface enhancement with contrast enhancement)	Control (HDWL) n=371 Participants HDWL (High definition white light)
Number of Participants With Conventional Adenoma Detected	174 Participants	140 Participants

Adverse Events

Intervention (I-scan)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (HDWL)

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

Trilokesh Kidambi

University of California San Francisco

Phone: 909-973-0629

Email: tkgastromd@gmail.com

Results disclosure agreements

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