ClinicalTrials.gg
Not yet recruitingNCT07338643Updated Jan 14, 2026

The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer

An observational study in Abdominal Pain, Black Stools and Constipation, sponsored by Limian Er. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by Limian Er · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,200
Sex
All
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Study summary

The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.

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Conditions studied

  • Abdominal Pain
  • Black Stools
  • Constipation
  • Diarrhea
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In context

Abdominal Pain

387 studies on the registry are indexed under Abdominal Pain; 58 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 127 across 80 observational studies indexed under Abdominal Pain.

Browse Abdominal Pain studies →

Lead sponsor

This is the only study on the registry with Limian Er as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.

Exclusion criteria

Exclusion Criteria:

  1. Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome
  2. Those with intestinal obstruction or malignant tumors
  3. Patients with colorectal lesions that need to be treated in stages.
  4. Other for colonoscopy examination.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,200 participants (estimated)
Patient registry
No

Groups and cohorts

  • AI group

    Procedure: AI group

  • Series group

    Procedure: Serial group

  • Standard group

    Procedure: Standard colonoscopy group

Interventions

  • ProcedureAI group

    Full AI assistance was used throughout the standard colonoscopy procedure.

  • ProcedureSerial group

    After normal withdrawal of the colonoscope to the splenic flexure during standard colonoscopy, full AI assistance was initiated. The colonoscope was re-entered to the ileocecal region for observation. Any missed lesions were recorded.

  • ProcedureStandard colonoscopy group

    The standard colonoscopy procedure was performed as usual

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What researchers measure

Primary outcomes

  1. Adenoma detection rate

    The proportion of patients who have at least one adenoma detected during colonoscopy examination

    Time frame: Day 1

  2. Average adenoma detection rate

    The result is the number of adenomas detected by colonoscopy divided by the total number of colonoscopies performed.

    Time frame: Day 1

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Study locations

1 site
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References and documents

Publications

  • Luo Y, Zhang Y, Liu M, Lai Y, Liu P, Wang Z, Xing T, Huang Y, Li Y, Li A, Wang Y, Luo X, Liu S, Han Z. Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study. J Gastrointest Surg. 2021 Aug;25(8):2011-2018. doi: 10.1007/s11605-020-04802-4. Epub 2020 Sep 23. PubMed 32968933 ↗
  • Wu J, Zhang Q, Li X, Bai T, Hou X, Li G, Song J. The Effect of the Second Forward View on the Detection Rate of Sessile Serrated Lesions in the Proximal Colon: A Single-Center Prospective Randomized Controlled Study. Clin Transl Gastroenterol. 2025 Feb 1;16(2):e00805. doi: 10.14309/ctg.0000000000000805. PubMed 39688959 ↗
  • Leggett B, Whitehall V. Role of the serrated pathway in colorectal cancer pathogenesis. Gastroenterology. 2010 Jun;138(6):2088-100. doi: 10.1053/j.gastro.2009.12.066. PubMed 20420948 ↗
  • Kim HY, Kim SM, Seo JH, Park EH, Kim N, Lee DH. Age-specific prevalence of serrated lesions and their subtypes by screening colonoscopy: a retrospective study. BMC Gastroenterol. 2014 Apr 28;14:82. doi: 10.1186/1471-230X-14-82. PubMed 24775268 ↗
  • Huang J, Chan PSF, Pang TWY, Choi P, Chen X, Lok V, Zheng ZJ, Wong MCS. Rate of detection of serrated lesions at colonoscopy in an average-risk population: a meta-analysis of 129,001 individuals. Endosc Int Open. 2021 Mar;9(3):E472-E481. doi: 10.1055/a-1333-1776. Epub 2021 Feb 19. PubMed 33655052 ↗
  • 王人杰, 张晓兰, 蔡继东, 等. 结直肠息肉的规范化诊疗[J]. 中华胃肠外科杂志, 2024, 27(6): 583-590.
  • 叶倩云,刘凤斌.大肠息肉发病相关风险因素及方法学研究[J].中华中医药杂志, 2018,33(3):4. DOI:CNKI:SUN:BXYY. 0.2018-03-080.
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Aug 2028, 29 months later.

Of 28 non-industry observational studies under Abdominal Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 38. This study's planned 29 months is above that.

Counting every sponsor, half of 37 studies reached it within 16 months; a quarter within 7 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Jan 14, 2026
StartEst.
Feb 26, 2026
Primary completionEst.
Aug 1, 2028
CompletionEst.
Aug 1, 2028
Last update
Jan 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07338643
Lead sponsor
Limian Er
Responsible party
Limian Er (The director of the Endoscopy Department of the Fourth Hospital of Hebei Medical University, Hebei Medical University Fourth Hospital) — Sponsor-investigator
First posted
Jan 14, 2026
Start date
Feb 26, 2026 (estimated)
Primary completion
Aug 1, 2028 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Jan 14, 2026

Study contacts

Li mian Er, doctor
Contact
Hbsyelm@163.com
13513379068
Zhenzhen Wang, master
Contact
13803365602@163.com
13803365602
Li mian Er
study director · Hebei Medical University Fourth Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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