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Completed

NCT Number: NCT03560128

Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

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Key information

Conditions

Colorectal Adenoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Colorectal Polyp Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40 years of age or older
  • Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
  • Able to provide written informed consent

Exclusion criteria

  • Active Inflammatory Bowel Disease
  • Prior resection of the colon
  • Referred for resection of a polyp identified by another physician
  • Referred for a previous incomplete colonoscopy

Treatment and study plan

Endocuff Vision device

Device

Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.

AmplifEYE device

Device

Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.

Primary outcomes

  1. Number of Adenomas Detected Per Colonoscopy (APC).

    Time frame: During colonoscopy procedure

    Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.

Secondary outcomes

  1. Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))

    Time frame: During colonoscopy procedure

    Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

    Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

  2. Complications Encountered During Procedure

    Time frame: During Colonoscopy procedure

    Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.

  3. Passage of Device Through Sigmoid Colon

    Time frame: during insertion portion of colonoscopy

    Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.

  4. Polyps Per Colonoscopy (PPC)

    Time frame: During colonoscopy procedure

    Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.

  5. Time Comparison for Each Method

    Time frame: During colonoscopy procedure

    Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

    Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps.

    Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps.

    Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.

  6. Cecal Intubation Rate

    Time frame: During Colonoscopy procedure

    Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.

  7. Detection of Serrated Lesions

    Time frame: During colonoscopy procedure

    Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

    Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2018
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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