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Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02730702
Enrollment
600
Registered
2016-04-06
Start date
2016-09-30
Completion date
2020-09-30
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Brief summary

This is a study whose focus is on understanding the clinical utility of rectal ultrastructure in detecting colonic neoplasm. The method uses Low-coherence Enhanced Backscattering Spectroscopy (LEBS).

Detailed description

The investigators use an optic probe which is a small device that uses light to assess the colon tissue. This probe will be used to identify subjects who do and do not have precancerous changes in the colon by capturing the light reflected back from the rectal wall and that will be assessed without the need for colonoscopy and bowel preparation (i.e unprepped). This device may detect early cancerous changes in colon tissue with higher accuracy than current tests.

Interventions

DEVICELEBS - Low coherence enhanced backscattering

Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.

Sponsors

American BioOptics, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- Subjects are eligible if they were scheduled for colonoscopy for colon cancer screening or surveillance

Exclusion criteria

* age \<50 * personal/family history of colonic neoplasia * personal history of coagulopathy * (retrospectively) failure to complete or inadequate colonoscopy * any patients harboring non-pathoglocially normal rectum (i.e. presence of lesion, inflammation, polyp, adenomas at rectum)

Design outcomes

Primary

MeasureTime frame
Whether rectal LEBS readings can predict the presence of advanced adenomas in the colon.Through study completion, an average of 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026