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Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy

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ClinicalTrials.gov Identifier: NCT04192929
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Douglas K. Rex, Indiana University

Brief Summary:
Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Device: Narrow band imaging Other: Chromoendoscopy Other: High definition white light endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1065 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Randomization cards will be sealed and opened after the subject is deemed eligible for the study by the PI. This will be done in an area away from the subject but due to the nature of the study, PI can't be blinded.
Primary Purpose: Screening
Official Title: Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
Actual Study Start Date : April 21, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: High definition white light endoscopy
colonoscopy performed using high definition equipment
Other: High definition white light endoscopy
High definition equipment will be used to perform colonoscopy

Active Comparator: Chromoendoscopy
indigo carmine is sprayed on the colon mucosa during withdrawal phase
Other: Chromoendoscopy
Indigo carmine will be sprayed during withdrawal phase of colonoscopy

Experimental: Narrow band imaging
Narrow band imaging is used during withdrawal phase
Device: Narrow band imaging
Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes




Primary Outcome Measures :
  1. Adenomas per colonoscopy [ Time Frame: during the procedure ]
    total number of adenomas divided by total number of procedures


Secondary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: during the procedure ]
    total number of patients with adenomas divided by total number of procedures

  2. Sessile serrated polyps per colonoscopy [ Time Frame: during the procedure ]
    total number of sessile serrated polyps divided by total number of procedures

  3. Sessile serrated polyp detection rate [ Time Frame: during the procedure ]
    total number of patients with sessile serrated polyps divided by total number of procedures

  4. Withdrawal time [ Time Frame: during the procedure ]
    Time from cecal intubation to end of the procedure

  5. Inspection time [ Time Frame: during the procedure ]
    Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 40 years
  2. Referral for screening, surveillance or diagnostic colonoscopy

Exclusion Criteria:

  1. Inflammatory bowel disease
  2. History of colorectal cancer or colon resection
  3. Indication of positive FIT or cologuard
  4. Any colorectal cancer syndromes (FAP, HNPCC, SPS)
  5. Patient with poor bowel preparation identified during insertion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192929


Contacts
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Contact: Krishna Vemulapalli, MBBS 3179480117 kvemulap@iu.edu

Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Krishna Vemulapalli, MBBS       kvemulap@iu.edu   
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Douglas Rex, MD IU
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Responsible Party: Douglas K. Rex, Emeritus Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT04192929    
Other Study ID Numbers: 1912241137
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases