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Detection of Lung Pathologies Among Dialysis Patients Using Pulsenmore MC™ Device - Feasibility Study

NCT07028060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-19

No results posted yet for this study

Summary

PRIMARY OBJECTIVE: To measure success rate and identification of pathological lung B-lines, using novel mobile Self-scan ultrasound device (MC, by Pulsenmore), in chronic renal failure patients, pre and post dialysis.

SECONDARY OBJECTIVE: 1.To describe the difference in B-lines score (BLS), pre and post dialysis as measured by the new device.

2\. Examine the degree of agreement in the BLS performed by the new mobile , MC device to the traditional POCUS device.

3\. To describe the identification rate of lung atelectasis and pleural effusion by the study device compared to standard ultrasound machine STUDY DESIGN: A prospective, pilot, single-center study. INTERVENTION: Lung point of care ultrasound (POCUS) performed with a new ultrasound device, MC based on mobile phone among chronic renal failure patients pre and post dialysis. SAMPLE SIZE CONSIDERATIONS: As this is a feasibility study sample size was not calculated, we will perform convenience sample of 30 patients.

STUDY PROCEDURES: Lung point of care ultrasound (POCUS) performed with a new MC device on chronic renal failure patients pre and post dialysis.

The following data will be collected:

* Demographic factors: age, gender, ethnicity
* Medical history: medications, diabetes mellitus, hypertension, systemic diseases, Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD), height and weight
* Clinical data:

oDates of admission oTreatment: dialysis duration (years) oEssential: heart rate, blood pressure, saturation, weight. Dry weight, BMI. All before and after session

* US results- BLS detected from pictures collected by:

o the new MC device o the traditional POCUS device
* Detection of lung atelectasis by o the new MC device o the traditional POCUS device
* Detection of pleural effusion by o the new MC device o the traditional POCUS device

OUTCOMES AND ANALYSES:

* Agreement rate between the study MC device and the gold standard ultrasound machine for primary and secondary objectives.
* Time of study in each machine.

Conditions

  • Hemodialysis Patients

Interventions

DEVICE

PulseNmore MC™

novel mobile Self-scan ultrasound device, Pulsenmore MC™

Sponsors & Collaborators

  • PulseNmore

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2023-06-01
Completion
2023-12-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07028060 on ClinicalTrials.gov