Development and Evaluation of Rapid Bacterial Species Ide... | NCT06519032

Studies
Development and Evaluation of Rapid Bacterial Species Identification for Acid-Fast Bacilli Smear Using Image Analysis AI

NCT06519032

Sponsor

GramEye

Status

Recruiting

Last Update Posted

Jul 26, 2024Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Bacterial Infections

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2023Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Jul 12, 2024

First Submission Date that Met QC Criteria

Jul 19, 2024

First Posted Date

Jul 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2024

Last Update Posted Date

Jul 26, 2024Actual

Name	Class
Osaka University	OTHER
Keio University	OTHER
Fukujuji Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to develop AI that detects and classifies Acid-Fast Bacilli from microscope images using anonymized and fixed glass slides.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of concordance between AI-estimated results with actual culture results regarding the presence or absence of acid-fast bacteria	Evaluate the difference between actual medical record reports(such as culture results) and AI-estimated results regarding the presence or absence of acid-fast bacteria	Day1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients in whom acid-fast bacilli(AFB) smear test was ordered

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Specimens for microbiological testing, such as acid-fast bacilli(AFB) smear test , ordered at the hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tatsuya Yamada, M.D.	Contact	7028060149		tatsuya.yamada@grameye.com

Overall Officials

Name	Affiliation	Role
Satoshi Kutsuna, PhD,MD	Osaka University Medical Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osaka University Hospital	Recruiting	Suita	Osaka	5650871	Japan

Condition Browse Module

MeSH Terms

ID	Term
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided