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Laxative-free Colon Examination with AI-powered Radiology Study in Japan (LAXCLEAR Study)

Laxative-free Colon Examination with AI-powered Radiology Study in Japan

Okamoto Masaki

Boston Medical Sciences, Inc.

3-7-2 Nihonbashi-Honcho, Chuo-ku, Tokyo, MFPR Nihonbashi-Honcho Building

okamoto@b-ms.tech

Echigo Masahiro

Boston Medical Sciences, Inc.

14-10 Kodemmacho, Nihonbashi, Chuo-ku, Tokyo, Assorti Kodemmacho Liens

+81-50-1720-7410

echigo@b-ms.tech

Not Recruiting

April. 01, 2025

Interventional

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

diagnostic purpose

1. Participants must be at least 40 years of age at the time of signing the informed consent form (ICF).
2. Participants who tested positive for fecal occult blood within the past year or are suspected of having a colorectal neoplastic lesion and have been deemed by a physician to be candidates for outpatient colonoscopy.

1. Confirmed presence of colorectal cancer.
2. Confirmed diagnosis of inflammatory gastrointestinal diseases, such as gastrointestinal ulcers, appendicitis, diverticulitis, or ulcerative colitis.
3. Confirmed diagnosis of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome), based on Amsterdam criteria.
4. Presence of clear risk factors for undergoing colonoscopy.
5. History of colorectal resection.
6. Suspected gastrointestinal stenosis, intestinal obstruction, intestinal perforation, or toxic megacolon.
7. Considered to be at high risk for CT colonography and associated bowel preparation, including but not limited to:
- Individuals who are unable to follow instructions during the examination due to conditions such as claustrophobia or hearing impairment.
- Individuals with a history of hypersensitivity to iodine-based or barium-based contrast agents.

Both

Colorectal polyps

- CT colonography performed without laxative bowel preparation
- Standard optical colonoscopy

Sensitivity (per-lesion) for detecting colorectal polyps 6 mm or more on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy serving as the reference standard.

- Sensitivity and specificity (per-patient) for detecting colorectal polyps 6 mm or more, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard.
- Sensitivity and specificity (per-patient) for detecting colorectal polyps 10 mm or more, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard.
- Positive predictive value (per-lesion) for colorectal polyps 6 mm or more exceeding 0.72, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard.
- Sensitivity and positive predictive value (per-lesion) for colorectal polyps 10 mm or more, based on physician interpretation of laxative-free CT colonography using AIM4CRC, with optical colonoscopy as the reference standard.
- Clinical effectiveness of the Electronic Cleansing function provided by AIM4CRC.

+81-3-6779-8166

Mar. 12, 2025

+81-3-3542-2511

Mar. 12, 2025

+81-96-351-8000

Mar. 12, 2025

+81-86-462-1111

Mar. 12, 2025

No

none