FECAL-AI Study Evaluating Faex Health’s Stool Image Technology Registered on ClinicalTrials.gov

Prospective study will compare AI-derived features from Faex stool images with quantitative FIT plus colonoscopy/histopathology, in 250 Chilean participants.

BOULDER, CO, UNITED STATES, August 26, 2026 /EINPresswire.com/ -- Faex Health today announced that FECAL-AI, a prospective observational study evaluating Faex Health’s AI-based stool image analysis technology against quantitative fecal immunochemical testing (FIT), is now publicly registered on ClinicalTrials.gov under NCT07740122.

Officially titled “AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment,” FECAL-AI is recruiting adults at Hospital Dr. Sótero del Río in Santiago, Chile. The study is sponsored by Servicio de Salud Metropolitano Sur Oriente and is led by Principal Investigator Dr. Erik Manriquez.

Faex Health serves as the study’s technology and research collaborator, contributing the smartphone-based stool image capture platform and AI analysis that form a central investigational component of FECAL-AI. The collaboration combines the hospital team’s clinical research expertise and established screening workflow with Faex Health’s image-analysis technology to evaluate whether information derived from a smartphone stool image is meaningfully associated with established clinical measurements.

The study is designed to enroll 250 adults undergoing colorectal cancer screening or diagnostic evaluation. Participants capture stool images using the Faex Health mobile platform while undergoing established clinical testing. The primary analysis will evaluate associations between AI-derived stool-image features and quantitative FIT measurements, including FIT positivity. Secondary exploratory analyses will evaluate associations with colonoscopy and histopathological findings when available.

“Clinical validation only matters when new technology is tested rigorously against established measurements in real-world settings,” said Landon Nattrass, Co-Founder and CEO of Faex Health. “By combining the clinical expertise and infrastructure of Hospital Sótero del Río with Faex Health’s smartphone imaging and AI technology, we can evaluate transparently whether signals derived from a stool image correspond with quantitative FIT results and, exploratorily, with colonoscopy and histopathology. Registration as NCT07740122 makes that work publicly reviewable and marks an important step in building the evidence base around the platform.”

“As a Chilean, being able to help bring this work into Chile’s public healthcare system is especially meaningful to me,” said Nicholas Soza, Head of Operations at Faex Health. “What excites me most is the opportunity to build rigorous clinical evidence in a real-world setting alongside the team at Hospital Sótero del Río. If we can demonstrate that something as simple and accessible as a smartphone image can provide meaningful information about gastrointestinal health, the potential impact could extend well beyond this study and beyond Chile.”

Evaluating Smartphone Stool Imagery Against Established Clinical Measures

Faex Health is developing technology that applies computer vision and artificial intelligence to images of human stool captured with a conventional smartphone. The platform analyzes structured visual characteristics in those images so they can be studied alongside other gastrointestinal health data.

Within FECAL-AI, participants are adults referred for screening or diagnostic colonoscopy at Hospital Dr. Sótero del Río who have quantitative FIT testing planned or completed within a defined period surrounding stool-image submission. The study is designed to determine whether AI-derived image features show measurable associations with quantitative FIT results, while also exploring relationships with colonoscopy and histopathological findings when those data are available.

Faex Health’s technology is being used exclusively for research in this study. It does not diagnose colorectal cancer, replace FIT or physician evaluation, or influence participants’ clinical treatment decisions. No conclusions about clinical performance should be drawn until the study data have been appropriately analyzed.

A Clinical Research Collaboration Built Around Validation

FECAL-AI brings together complementary roles required for real-world clinical validation. Servicio de Salud Metropolitano Sur Oriente serves as the lead sponsor, Hospital Dr. Sótero del Río provides the clinical study setting and investigative team, and Faex Health provides the stool-image capture and AI analysis technology being evaluated. This structure allows the investigational technology to be studied within an established public-healthcare workflow and compared with clinically recognized measurements.

Faex Health first announced the Chilean clinical collaboration in May 2026. The assignment of NCT07740122 creates a permanent public identifier through which clinicians, researchers, healthcare organizations, journalists, investors and potential partners can independently review the registered study design and methodology.

The ClinicalTrials.gov record lists the study as recruiting, with an estimated enrollment of 250 participants. The study began in May 2026 and is expected to continue through 2026 as paired stool imagery and clinical data are collected.

Faex Health believes this research can help clarify whether computer vision applied to smartphone stool imagery may eventually provide useful complementary information within gastrointestinal screening and monitoring pathways. FECAL-AI is intended to generate the evidence needed to determine where that technology may or may not add value alongside existing tools.

Clinical Study Information

Official Study Title: AI-Based Stool Image Analysis for Colorectal Neoplasia Risk Assessment

Study Acronym: FECAL-AI

ClinicalTrials.gov Identifier: NCT07740122

Study Type: Prospective Observational

Recruitment Status: Recruiting

Estimated Enrollment: 250 participants

Study Location: Hospital Dr. Sótero del Río, Santiago, Chile

Lead Sponsor: Servicio de Salud Metropolitano Sur Oriente

Principal Investigator: Dr. Erik Manriquez

Technology and Research Collaborator: Faex Health

Technology Evaluated: Faex Health AI-Based Stool Image Analysis

Primary Comparison: AI-derived stool-image features compared with quantitative FIT measurements and FIT positivity

Additional Exploratory Comparisons: Colonoscopy and histopathological findings when available

The complete registered study can be found by searching NCT07740122 on ClinicalTrials.gov.

About Faex Health

Faex Health is a health technology company developing AI-powered tools that use smartphone stool imagery to generate structured information about gastrointestinal health. The company is researching how computer vision, longitudinal digital health data and accessible image capture can support new approaches to gastrointestinal monitoring and clinical research.

Faex Health’s platform is being evaluated across consumer, healthcare and clinical research applications, with a focus on building rigorous evidence around how everyday stool imagery can contribute meaningful health signals over time.

For more information, visit www.faexhealth.com.

Media Contact

Faex Health
press@faexhealth.com

Landon Nattrass
Faex Health
Press@FaexHealth.com
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