Trial Outcomes & Findings for Polyp Measurement Device (NCT NCT03856255)

NCT ID: NCT03856255

Last Updated: 2021-06-14

Results Overview

Scale of 1-10, with 1 being the easiest and 10 being the hardest

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: At the time of the procedure
• Results posted on: 2021-06-14

Participant Flow

Participant milestones

Measure	Micro-Tech Endoscopic Gauge Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Polyp Measurement Device

Baseline characteristics by cohort

Measure	Micro-Tech Endoscopic Gauge n=23 Participants Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	11 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	18 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Region of Enrollment United States	23 participants n=93 Participants

PRIMARY outcome

Timeframe: At the time of the procedure

Scale of 1-10, with 1 being the easiest and 10 being the hardest

Outcome measures

Measure	Micro-Tech Endoscopic Gauge n=23 Participants Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel	21 Participants

PRIMARY outcome

Timeframe: At the time of of the procedure

Scale of 1-10, with 1 being the easiest and 10 being the hardest

Outcome measures

Measure	Micro-Tech Endoscopic Gauge n=23 Participants Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Mean Score Indicating Ease of Extending and Retracting the Device	1.43 score on a scale Standard Error 0.21

PRIMARY outcome

Timeframe: At the time of the procedure

Scale of 1-10, with 1 being the easiest and 10 being the hardest

Outcome measures

Measure	Micro-Tech Endoscopic Gauge n=23 Participants Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Mean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement	2.62 score on a scale Standard Error 0.40

PRIMARY outcome

Timeframe: At the time of the procedure

Scale of 1-10, with 1 being the easiest and 10 being the hardest

Outcome measures

Measure	Micro-Tech Endoscopic Gauge n=23 Participants Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Mean Score Indicating Ease of Use in Taking a Picture That Included the Measuring Device and Polyp in Order to Photo-document the Measurement Reading	2.17 score on a scale Standard Error 0.87

SECONDARY outcome

Timeframe: At the time of the procedure

The size of the polyp measured by the device will be subtracted from the size of the polyp as measured by the standard, device-free optical visualization.

Outcome measures

Measure	Micro-Tech Endoscopic Gauge n=23 Participants Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Mean Difference in Size of Polyp	0.28 mm Standard Error 0.21

Adverse Events

Micro-Tech Endoscopic Gauge

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

Mark Pochapin, MD

NYU Langone Health

Phone: 212-263-9177

Email: Mark.Pochapin@nyulangone.org

Results disclosure agreements

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