The usefulness of AIM in colonoscopy

A multicenter, open-label, single-blind, randomized, parallel-group study to evaluate the utility of indigocarmine and acetic acid-indigocarmine mixture (AIM) for the diagnosis of colonic serrated lesions in the right side colon - A multicenter, open-label, single-blind, randomized, parallel-group study to evaluate the utility of indigocarmine and acetic acid-indigocarmine mixture (AIM) for the diagnosis of colonic serrated lesions in the right side colon (cAIM study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061210002

Enrollment

1311

Registered

2021-04-16

Start date

2021-04-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serrated lesion Serrated lesion

Interventions

Randomized controlled trial

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who are between 20 years and 90 years old at the time of obtaining consent (2) A person for whom the patient's written consent has been obtained (3) Patients who are scheduled for screening colonoscopy (e.g., fecal occult blood, cancer screening, and colonoscopy with no endoscopic treatment within 1 year)

Exclusion criteria

Exclusion criteria: (1) Familial colorectal adenomatosis, Lynch syndrome, serrated polyp syndrome(SPS) (2) Patients with a history of colorectal cancer surgery (3) Patients with endoscopic treatment of the colon within 1 year (4) Ulcerative colitis and Crohn's disease (5) Difficulty with endoscopic examination and treatment due to inability to temporarily stop taking antithrombotic or anticoagulant drugs (6) Patents with an infectious disease that requires systemic treatment (7) Pregnant and lactating women (8) Patients with a history of hypersensitivity to indigocarmine or acetic acid (9) Patients who are deemed unsuitable as research subjects by the principal investigator or sub-researcher

Design outcomes

Primary

Measure	Time frame
Additional effect of AIM on detection of colonic serrated lesions including SSL	—

Secondary

Measure	Time frame
(1) Addirional effect of each group for detection of colorectal polyps (2) Additional effect of each group for detection of colorectal adenoma (3) Additional effect of each group for detection of SSL (4) Factors contributing to the additional effect of each group (5) Differences in additional effect among endoscopists (6) Treatment time (7) Incidental disease (posterior bleeding, perforation, and adverse events associated with colonoscopy) (8) Percentage of colorectal adenomas and colonic serrated lesions in the right side colon	—

Measure

Time frame

(1) Addirional effect of each group for detection of colorectal polyps (2) Additional effect of each group for detection of colorectal adenoma (3) Additional effect of each group for detection of SSL (4) Factors contributing to the additional effect of each group (5) Differences in additional effect among endoscopists (6) Treatment time (7) Incidental disease (posterior bleeding, perforation, and adverse events associated with colonoscopy) (8) Percentage of colorectal adenomas and colonic serrated lesions in the right side colon

—

Contacts

Public ContactHideaki Kinugasa

Okayama University Hospital

hkinugasa14@okayama-u.ac.jp+81-86-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026