Colorectal NeoplasmsNCT04192929
Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
A study testing Narrow band imaging, Chromoendoscopy and High definition white light endoscopy in people with Colorectal Neoplasms, run by Indiana University at 1 site in United States.
Trial summary
Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Narrow band imaging, Chromoendoscopy and High definition white light endoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2025to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 40 years
- Referral for screening, surveillance or diagnostic colonoscopy
Who cannot join
- Inflammatory bowel disease
- History of colorectal cancer or colon resection
- Indication of positive FIT or cologuard
- Any colorectal cancer syndromes (FAP, HNPCC, SPS)
- Patient with poor bowel preparation identified during insertion
Trial locations and contacts
1 site in 1 country.
About this study
Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.
- Conditions
- Colorectal Neoplasms
- Being tested
- Narrow band imaging, Chromoendoscopy, High definition white light endoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrow band imagingDevice
Blue light is used during withdrawal phase instead of the regular white light to highlight surface changes
ChromoendoscopyOther
Indigo carmine will be sprayed during withdrawal phase of colonoscopy
High definition white light endoscopyOther
High definition equipment will be used to perform colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| High definition white light endoscopy | Placebo comparator | colonoscopy performed using high definition equipment Receives: Other: High definition white light endoscopy |
| Chromoendoscopy | Active comparator | indigo carmine is sprayed on the colon mucosa during withdrawal phase Receives: Other: Chromoendoscopy |
| Narrow band imaging | Experimental | Narrow band imaging is used during withdrawal phase Receives: Device: Narrow band imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenomas per colonoscopy
total number of adenomas divided by total number of procedures
Measured: during the procedure
Secondary outcomes (5)
Adenoma detection rate
total number of patients with adenomas divided by total number of procedures
Measured: during the procedure
Sessile serrated polyps per colonoscopy
total number of sessile serrated polyps divided by total number of procedures
Measured: during the procedure
Sessile serrated polyp detection rate
total number of patients with sessile serrated polyps divided by total number of procedures
Measured: during the procedure
Withdrawal time
Time from cecal intubation to end of the procedure
Measured: during the procedure
Inspection time
Time during withdrawal minus time for interventions including washing, suctioning and polypectomy or biopsies
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study startFeb 2025 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Why it stopped: PI decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas K. Rex, Indiana University
- Investigators
- Douglas Rex, MD, Principal investigator, IU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192929
- Sponsor's protocol ID
- 1912241137
- Status last verified
- Oct 2023
- First submitted
- 6 Dec 2019
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wieszczy P, Regula J, Kaminski MF. Adenoma detection rate and risk of colorectal cancer. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):441-446. doi: 10.1016/j.bpg.2017.07.002. Epub 2017 Jul 6.
PubMed 28842054Brown SR, Baraza W, Din S, Riley S. Chromoscopy versus conventional endoscopy for the detection of polyps in the colon and rectum. Cochrane Database Syst Rev. 2016 Apr 7;4(4):CD006439. doi: 10.1002/14651858.CD006439.pub4.
PubMed 27056645Nagorni A, Bjelakovic G, Petrovic B. Narrow band imaging versus conventional white light colonoscopy for the detection of colorectal polyps. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008361. doi: 10.1002/14651858.CD008361.pub2.
PubMed 22258983Leung WK, Lo OS, Liu KS, Tong T, But DY, Lam FY, Hsu AS, Wong SY, Seto WK, Hung IF, Law WL. Detection of colorectal adenoma by narrow band imaging (HQ190) vs. high-definition white light colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2014 Jun;109(6):855-63. doi: 10.1038/ajg.2014.83. Epub 2014 Apr 22.
PubMed 24751581Atkinson NSS, Ket S, Bassett P, Aponte D, De Aguiar S, Gupta N, Horimatsu T, Ikematsu H, Inoue T, Kaltenbach T, Leung WK, Matsuda T, Paggi S, Radaelli F, Rastogi A, Rex DK, Sabbagh LC, Saito Y, Sano Y, Saracco GM, Saunders BP, Senore C, Soetikno R, Vemulapalli KC, Jairath V, East JE. Narrow-Band Imaging for Detection of Neoplasia at Colonoscopy: A Meta-analysis of Data From Individual Patients in Randomized Controlled Trials. Gastroenterology. 2019 Aug;157(2):462-471. doi: 10.1053/j.gastro.2019.04.014. Epub 2019 Apr 15.
PubMed 30998991
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromoendoscopy or Narrow Band Imaging (NBI) for Improving Adenoma Detection in Colonoscopy
- ClinicalTrials.gov ID
- NCT04192929
- Acronym / sponsor ID
- 1912241137
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High definition white light endoscopy | Placebo comparator | Other: High definition white light endoscopycolonoscopy performed using high definition equipment |
| Chromoendoscopy | Active comparator | Other: Chromoendoscopyindigo carmine is sprayed on the colon mucosa during withdrawal phase |
| Narrow band imaging | Experimental | Device: Narrow band imagingNarrow band imaging is used during withdrawal phase |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 40 years
- Referral for screening, surveillance or diagnostic colonoscopy
Key exclusion criteria (5 listed)
- Inflammatory bowel disease
- History of colorectal cancer or colon resection
- Indication of positive FIT or cologuard
- Any colorectal cancer syndromes (FAP, HNPCC, SPS)
- Patient with poor bowel preparation identified during insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrow band imagingBlue light is used during withdrawal phase instead of the regular white light to highlight surface changes | Device | Narrow band imaging |
| ChromoendoscopyIndigo carmine will be sprayed during withdrawal phase of colonoscopy | Other | Chromoendoscopy |
| High definition white light endoscopyHigh definition equipment will be used to perform colonoscopy | Other | High definition white light endoscopy |
Primary outcome
Adenomas per colonoscopy
Time frame: during the procedure
total number of adenomas divided by total number of procedures
5 secondary outcomes
Adenoma detection rate
Time frame: during the procedure
Sessile serrated polyps per colonoscopy
Time frame: during the procedure
Sessile serrated polyp detection rate
Time frame: during the procedure
Withdrawal time
Time frame: during the procedure
Inspection time
Time frame: during the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Background: PubMed 28842054Wieszczy P, Regula J, Kaminski MF. Adenoma detection rate and risk of colorectal cancer. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):441-446. doi: 10.1016/j.bpg.2017.07.002. Epub 2017 Jul 6.
- Background: PubMed 27056645Brown SR, Baraza W, Din S, Riley S. Chromoscopy versus conventional endoscopy for the detection of polyps in the colon and rectum. Cochrane Database Syst Rev. 2016 Apr 7;4(4):CD006439. doi: 10.1002/14651858.CD006439.pub4.
- Background: PubMed 22258983Nagorni A, Bjelakovic G, Petrovic B. Narrow band imaging versus conventional white light colonoscopy for the detection of colorectal polyps. Cochrane Database Syst Rev. 2012 Jan 18;1(1):CD008361. doi: 10.1002/14651858.CD008361.pub2.
- Background: PubMed 24751581Leung WK, Lo OS, Liu KS, Tong T, But DY, Lam FY, Hsu AS, Wong SY, Seto WK, Hung IF, Law WL. Detection of colorectal adenoma by narrow band imaging (HQ190) vs. high-definition white light colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2014 Jun;109(6):855-63. doi: 10.1038/ajg.2014.83. Epub 2014 Apr 22.
- Background: PubMed 30998991Atkinson NSS, Ket S, Bassett P, Aponte D, De Aguiar S, Gupta N, Horimatsu T, Ikematsu H, Inoue T, Kaltenbach T, Leung WK, Matsuda T, Paggi S, Radaelli F, Rastogi A, Rex DK, Sabbagh LC, Saito Y, Sano Y, Saracco GM, Saunders BP, Senore C, Soetikno R, Vemulapalli KC, Jairath V, East JE. Narrow-Band Imaging for Detection of Neoplasia at Colonoscopy: A Meta-analysis of Data From Individual Patients in Randomized Controlled Trials. Gastroenterology. 2019 Aug;157(2):462-471. doi: 10.1053/j.gastro.2019.04.014. Epub 2019 Apr 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Rex, MD principal investigator
IU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrow band imaging, Chromoendoscopy and High definition white light endoscopy in people with Colorectal Neoplasms, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenomas per colonoscopy (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192929, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.