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Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

M

Michael Wallace

Status

Completed

Conditions

Post-endoscopic Mucosal Resection of Colon Polyps

Treatments

Device: Olympus CF190 Colonoscope Narrow band imaging with near focus
Device: Olympus CF190 Colonoscope White light with near focus
Device: Olympus CF190 Colonoscope Narrow band imaging
Device: Olympus CF190 Colonoscope High definition white light
Procedure: Biopsy

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02668198
15-007241

Details and patient eligibility

About

The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR

Full description

Residual neoplasia after EMR is a common. Optimal surveillance protocols are not clearly defined. There is a need for better imaging modalities to evaluate for residual disease. Suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. However, this can lead to either frequent colonoscopy or overtreatment. This presents more cost and financial burden to the patient. With the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. With better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous EMR may be avoided. Furthermore, the interval for surveillance colonoscopy can be lengthened.

Enrollment

230 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Post-EMR follow up at 6-12 months

Exclusion criteria

  • Non-corrected coagulopathy
  • Pregnancy
  • Breast feeding

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

230 participants in 1 patient group

Endoscopic scar assessment
Experimental group
Description:
Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Treatment:
Procedure: Biopsy
Device: Olympus CF190 Colonoscope High definition white light
Device: Olympus CF190 Colonoscope Narrow band imaging
Device: Olympus CF190 Colonoscope White light with near focus
Device: Olympus CF190 Colonoscope Narrow band imaging with near focus

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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