RECRUITING

The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases. Phase 1 will use SimpleSense data collected from the first set of subjects and associate the data from SimpleSense to the right heart catheterization values.' Phase 2 will evaluate the algorithms developed to estimate cardiac output from SimpleSense data using a second set of subjects from within the sample population that are sequestered from the first set used for association of data from SimpleSense to the data from the right heart catheterization.

Official Title

The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output, Cardiac Power Output and Pulmonary Artery Pressure.in Patients Undergoing Right Heart Catheterization

Quick Facts

Study Start:2023-03-08
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05629533

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has provided informed consent
  2. 2. Male or female over the age of 18 years
  3. 3. The patient is undergoing right heart catheterization
  1. 1. Subject unwilling or unable to comply with wearing the Nanowear SimpleSense System.
  2. 2. Subjects who are pregnant
  3. 3. Severe aortic stenosis.

Contacts and Locations

Study Contact

Venk Varadan
CONTACT
(718) 637-4815
venk@nanowearinc.com
Alan Gass, MD
CONTACT
(845) 368-8800
alan.gass@wmchealth.org

Study Locations (Sites)

Westchester Medical Center
Valhalla, New York, 10595
United States

Collaborators and Investigators

Sponsor: Nanowear Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-08
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2023-03-08
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • Cardiac output
  • Right heart catheterization
  • SimpleSense
  • Algorithm
  • Pulmonary Artery Pressure
  • Heart failure
  • Endomyocardial biopsy
  • Cardiogenic shock

Additional Relevant MeSH Terms

  • Right Heart Catheterization