Trial Outcomes & Findings for Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods (NCT NCT02668198)

NCT ID: NCT02668198

Last Updated: 2019-10-17

Results Overview

The number of positive diagnoses using white light optical imaging only.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 230 participants
• Primary outcome timeframe: approximately 6 to 12 months post endoscopic mucosal resection
• Results posted on: 2019-10-17

Participant Flow

Participant milestones

Measure	Endoscopic Scar Assessment Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior endoscopic mucosal resection (EMR) site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging (NBI) with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Endoscopic colorectal mucosal resection
Overall Study STARTED	230
Overall Study COMPLETED	230
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Endoscopic colorectal mucosal resection
Age, Continuous	65.5 years n=230 Participants
Sex: Female, Male Female	113 Participants n=230 Participants
Sex: Female, Male Male	117 Participants n=230 Participants
Region of Enrollment United States	230 participants n=230 Participants

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of positive diagnoses using white light optical imaging only.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using White Light Imaging

66 adenomas with positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology

56 adenomas confirmed positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of positive diagnoses using white light near focus optical imaging only.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using White Light Near Focus Imaging

70 adenomas with positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of recurrent adenomas diagnosed positive with white light imaging near focus confirmed by standard histopathology of biopsy.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology

57 adenomas confirmed positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of positive diagnoses using narrow band optical imaging only.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using Narrow Band Imaging

68 adenomas with positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of recurrent adenomas diagnosed positive with narrow band imaging confirmed by standard histopathology of biopsy.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology

57 adenomas confirmed positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of positive diagnoses using narrow band optical imaging near focus only.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus

70 adenomas with positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology

58 adenomas confirmed positive diagnoses

PRIMARY outcome

Timeframe: approximately 6 to 12 months post endoscopic mucosal resection

The number of positive diagnoses determined by standard histopathology assessment of biopsy.

Outcome measures

Measure

Endoscopic Scar Assessment n=230 Participants Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Positive Recurrent Adenomas Using Biopsy

62 adenomas with positive diagnoses

Adverse Events

Endoscopic Scar Assessment

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

Dr. Michael B. Wallace

Mayo Clinic

Phone: 904-953-2221

Email: wallace.michael@mayo.edu

Results disclosure agreements

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