An interventional study of Colonoscopy quality bundle in Colorectal Cancer Screening and Colonoscopy, sponsored by Indiana University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Indiana University · Not applicable, Interventional, and Health services research
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Among 17 studies in Colorectal Neoplasms by Indiana University — 3 open to participants now, 3 under way, none of them phase 3. Colorectal Neoplasms · Indiana University.
Among the 17 studies in Colorectal Neoplasms by Indiana University, this one is the 10th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2026, is one of 12 with no phase, and was the 17th registered.
6,545 studies on the registry are indexed under Colorectal Neoplasms; 1,664 are open to participants now.
Browse Colorectal Neoplasms studies →3 of the 17 studies in Colorectal Neoplasms by Indiana University are open now, in 1 country. Recruiting first, the newest first:
Indiana University · Sites in United States
Ages 18+ · Healthy volunteers
Indiana University · Sites in United States
Ages 45–75 · Healthy volunteers
By country, each count listing its studies:
Of the 1,181 Colorectal Neoplasms studies recruiting now, 764 (65%) set no upper age limit and 264 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 15 is below the median of 76 across 4,802 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 503 across the 12 interventional studies, 400 across the 5 observational. Of the 13 that completed or were terminated, 6 (46%) have results posted.
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Indiana University is the lead sponsor of 988 studies on the registry; 200 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
1 of the studies in Colorectal Neoplasms by Indiana University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06597955Indiana UniversityLarge-Scale Implementation of a Decision Aid About Colorectal Cancer Screening | 2026-12 |
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Among the 17 studies in Colorectal Neoplasms by Indiana University, from their registry updates:
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The goals of this project are to learn whether a quality improvement report card assessing technical skills from AI-augmented expert review of video recordings improves doctors' colonoscopy performance. Colonoscopy performance is important because colonoscopies are how doctors detect and remove pre-cancerous polyps. The participants in this study are doctors, usually surgeons, who perform some colonoscopies as part of their practice. These doctors usually do not receive feedback on their performance, and therefore lack information on how to potentially improve their ability to detect and remove pre-cancerous polyps.
The main questions it aims to answer are:
(2) Does the colonoscopy quality improvement report card improve doctors' colonoscopy performance?
Colonoscopy reduces the risk of colorectal cancer (CRC) mortality through the detection and removal of pre-cancerous polyps (adenomas), but the magnitude of risk reduction depends upon the quality of the colonoscopy. Most colonoscopy quality improvement (QI) initiatives have focused on higher-volume gastroenterologists. In rural and peri-urban communities in the United States, most colonoscopies are performed by lower-volume colonoscopists, who are mostly surgeons, and CRC outcomes are worse compared to urban areas. These lower-volume colonoscopists have marked variability in quality and many fail to adhere to best practices or meet national benchmarks. Higher adenoma detection rate (ADR) is the quality metric most associated with reduced CRC mortality. However, ADR is less accurate at lower colonoscopy volumes, suggesting that ADR alone cannot reliably differentiate quality or provide meaningful information to improve quality in lower-volume colonoscopists. Thus, alternative methods to measure and improve quality in lower-volume colonoscopists are needed. Video evaluation of procedures such as colonoscopy is a valuable tool for assessing and improving technical skills in multiple specialties. In prior work, we found that higher-volume gastroenterologists' colonoscopy skill, assessed by expert evaluation of video-recorded colonoscopies using a validated technical skill scoring rubric, is highly correlated with quality metrics requires fewer colonoscopies for accurate assessment, and correlates with ADR. Further, we showed that delivery of focused feedback based on technical skill scores improves colonoscopy quality. While expert video evaluation of colonoscopies is an effective tool to measure and improve quality in lower-volume colonoscopists, it is not feasible on a larger scale given the time and cost of manual video review. We therefore developed and validated an AI-based tool that identifies key steps in colonoscopy videos, for rapid expert review and scoring. This study focuses on the implementation and evaluation of an AI-augmented intervention to improve colonoscopy quality of lower-volume colonoscopists in rural and peri-urban areas to ultimately reduce CRC mortality. The intervention, the "Colonoscopy Quality Improvement Bundle" (ColonQI Bundle), combines (1) AI-augmented expert assessment and scoring of technical skills; (2) AI-augmented automated calculation of quality metrics (e.g., ADR, withdrawal time), and (3) Targeted feedback of specific technical skill deficits based on the scores (audit-feedback, structured video-based didactics, coaching, mentoring). Lower-volume colonoscopists, with a focus on surgeons will be recruited to: (1) Assess the needs and preferences of, and select strategies for implementation of the ColonQI Bundle using an implementation science framework; (2) Implement the ColonQI Bundle, using tailored implementation strategies tailored to the needs and preferences of lower-volume colonoscopists; and (3) Assess the effectiveness of the ColonQI Bundle to improve colonoscopy quality and technical skills among lower-volume colonoscopists.
Inclusion Criteria:
Participating colonoscopists will receive the Colonoscopy Quality Improvement Bundle
Other: Colonoscopy quality bundle
The "Colonoscopy Quality Improvement Bundle" (ColonQI Bundle) combines (1) calculation of quality metrics (e.g., CIR, WT); (2) AI-augmented expert technical skills assessment; and (3) targeted feedback of specific technical skill deficits (audit-feedback, structured video-based didactics, coaching, mentoring).
Pre-post Change in Adenoma Detection Rate (ADR) at the individual and cohort levels
The rate at which a colonoscopist detects adenomas (pre-cancerous polyps) during a colonoscopy in an average-risk population.
Time frame: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
Colonoscopist technical skill scores (E-CTSS) assessed by expert review of video-recorded colonoscopies at the individual and cohort levels
Total E-CTSS score; composite of 3 individually scored skills (cleaning, distention, and examination behind colon folds)
Time frame: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
Pre-post Change in Withdrawal time (WT) at the individual and cohort levels
Time spent inspecting the colon for polyps in screening and surveillance colonoscopies (not including time spent on polyp removal or biopsies)
Time frame: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
Pre-post change in Sessile serrated polyp detection rate (SDR) at the individual and cohort levels
Proportion of colonoscopies in which a serrated polyp is removed
Time frame: From baseline (the end of the pre-ColonQI Bundle period, prior to the delivery of the ColonQI Bundle) through study completion, an average of 1.5 years.
No study locations are listed for this record.
Plan to share: Yes — all IPD that underlie results in a publication
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
Of 899 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 23 months is below that.
Counting every sponsor, half of 956 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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