Novel On-body Evaluation of Cardiac Health for Oncology

NCT ID: NCT07158450

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-09

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiotoxicity Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy

No known or suspected cardiac disease

No interventions assigned to this group

Borderline LVEF

Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction

No interventions assigned to this group

Reduced LVEF

Known diagnosis of reduced left ventricular ejection fraction

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Undergoing an echocardiogram irrespective of participation in this study
* Willing and able to provide informed consent prior to any study-related activity

Exclusion Criteria

* Have a documented allergy to potential tissue contacting system materials
* Have been diagnosed with one or more of the following cardiac diseases/conditions that distort cardiac activity:

1. Severe valve disease
2. Severe right ventricular dilation or dysfunction
3. Significant arrhythmias or conduction abnormalities
4. Active ischemia or myocardial infarction within the last 3 months
* Have an active implantable cardiac device
* Have any condition that would cause inaccurate TTE measurements
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Rochester

OTHER

Sponsor Role collaborator

Skribe Medical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Strong Memorial Hospital

Rochester, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SKR-LVEF-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.