Truway Health Releases ICE-ACCESS Clinical Study Record to ClinicalTrials.gov PRS Review

New observational research program will examine intracardiac echocardiography catheter availability, procurement reliability, supply-chain disruption, and their potential effects on timely cardiovascular care.

August 23, 2026 — Truway Health News & Insights

Truway Health, Inc. today announced the release of its new clinical research protocol, TH-ICEACCESS-2026-001, titled “Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study,” through the ClinicalTrials.gov Protocol Registration and Results System (PRS).

The study record was released within PRS on August 23, 2026 and is presently undergoing ClinicalTrials.gov PRS review. An NCT number has not yet been assigned, and the study is not yet displayed as a registered study on the ClinicalTrials.gov public site.

Studying the Connection Between Device Supply and Clinical Access

The ICE-ACCESS study is structured as a prospective observational investigation examining how real-world access to intracardiac echocardiography (ICE) catheters may influence cardiovascular procedure readiness and healthcare delivery.

Intracardiac echocardiography catheters are specialized medical devices used to provide real-time imaging during electrophysiology, cardiac ablation, structural-heart, and other cardiovascular procedures. Access to these devices can depend upon a complex network of manufacturers, reprocessors, distributors, procurement organizations, logistics providers, healthcare facilities, and clinical teams.

ICE-ACCESS is designed to systematically document this pathway.

The research will evaluate events including:

• ICE catheter procurement and fulfillment timelines;

• product availability and sourcing attempts;

• backorders and allocation events;

• order rejection or cancellation;

• distributor or purchasing restrictions;

• shipping and logistical delays;

• device substitution and alternative sourcing;

• acquisition-cost variability;

• procedure rescheduling or delay associated with documented access disruption; and

• the administrative burden required to obtain clinically relevant devices.

Two Prospective Observational Cohorts

The protocol establishes two principal observational cohorts.

The ICE Catheter Access Disruption Cohort will include qualifying participants whose associated device-procurement episode involves a predefined access disruption such as non-fulfillment, backorder, cancellation, restriction, delayed shipment, or required device substitution.

The Timely ICE Catheter Access Cohort will serve as the observational comparison population and will include qualifying participants whose required ICE catheter is obtained without a defined supply-chain disruption.

The study does not intentionally withhold medical devices, create shortages, or assign participants to delayed treatment. Clinical care and device selection remain under the authority of treating healthcare professionals.

Measuring Procurement Reliability

Primary and secondary research outcomes are designed to quantify the operational and clinical dimensions of device access.

Planned measures include:

• time from initial procurement request to successful device fulfillment;

• incidence of qualifying ICE catheter supply-chain disruptions;

• frequency of procedure delay associated with device access;

• time between planned and actual procedure dates;

• procedure rescheduling and cancellation rates;

• ICE catheter substitution rates;

• number of procurement attempts required for successful access;

• order non-fulfillment rates;

• procurement-related administrative burden;

• variation in device acquisition costs; and

• time required to establish an alternative device source.

The protocol also contemplates an exploratory Medical Device Access Disruption Index designed to characterize the cumulative burden of multiple procurement-related events within a single access episode.

Building a Traceable Medical-Device Access Dataset

A central objective of ICE-ACCESS is to convert fragmented procurement and clinical-access events into a structured, auditable research dataset.

Protocol-authorized records may include purchase requests, quotations, purchase orders, order confirmations, cancellation notices, shipping records, device identifiers, sourcing histories, availability communications, procedure scheduling information, and other contemporaneous records relevant to the study endpoints.

Truway Health is also developing supporting digital integrity architecture for the study, including serialized research events, cryptographic document hashing, device-level identifiers, RFID/NFC-supported custody models, and controlled audit trails. These systems are intended to support provenance and data integrity while maintaining separation between identifiable patient information and device-distribution records.

Research Without Predetermining Liability

ICE-ACCESS is designed to record and analyze objectively documented events. The protocol does not presume that a particular manufacturer, distributor, supplier, healthcare organization, or other party is responsible for a specific disruption.

Instead, the research framework distinguishes among reported inventory limitations, logistics delays, allocation policies, account requirements, purchasing restrictions, cancellations, product substitutions, and other documented causes of non-fulfillment.

This distinction is intended to support rigorous analysis of medical-device supply resilience while preserving the difference between research observations and legal or regulatory conclusions.

A Broader Healthcare Supply-Chain Research Strategy

The launch of ICE-ACCESS reflects Truway Health's continuing interest in the intersection of medical-device availability, healthcare procurement, clinical operations, digital traceability, and patient access.

Modern healthcare increasingly depends upon the reliability of supply networks operating behind the clinical environment. A procedure may require not only a trained clinical team and appropriate facility, but also the timely coordination of specialized devices, regulatory controls, inventory systems, freight networks, and purchasing infrastructure.

ICE-ACCESS seeks to make those dependencies measurable.

By studying the interval between clinical need, procurement request, device availability, and procedure completion, Truway Health intends to develop data that may contribute to improved procurement practices, stronger medical-device supply resilience, more transparent access metrics, and future research into the relationship between supply-chain performance and healthcare delivery.

ClinicalTrials.gov Status

Protocol ID: TH-ICEACCESS-2026-001
Brief Title: Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
Study Type: Observational
PRS Initial Release: August 23, 2026
ClinicalTrials.gov PRS Review: Pending
NCT Number: Not yet assigned
Public ClinicalTrials.gov Registration: Pending PRS processing

The record's release to PRS represents an important administrative milestone but should not be interpreted as final ClinicalTrials.gov registration or assignment of an NCT identifier. Truway Health will update the study information following completion of the applicable PRS review process.

About Truway Health, Inc.

Truway Health, Inc. develops and distributes healthcare products, medical technologies, procurement solutions, and clinical research programs focused on improving access, traceability, operational resilience, and healthcare delivery.

Through its clinical research and healthcare technology initiatives, Truway Health explores emerging relationships among medical devices, clinical operations, digital infrastructure, supply-chain systems, and measurable patient-care outcomes.

Research Identifier: TH-ICEACCESS-2026-001
Program: ICE-ACCESS
Release Classification: Clinical Research / Medical Device Supply Chain / Healthcare Access
Release Date: August 23, 2026

This announcement describes a research protocol and its administrative status. It does not constitute a claim of ClinicalTrials.gov registration, regulatory approval, clinical efficacy, or a determination of wrongdoing by any manufacturer, supplier, distributor, healthcare organization, or other party.