CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
PulseNmore MC™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07028060
NCT07028060N/ACompleted

The Detection of Lung Pathologies Among Dialysis Patients Using Novel Mobile-Phone Ultrasound - A Feasibility Pilot Study

PulseNmore·interventional·Posted Jun 19, 2025·Updated Jun 19, 2025

In Brief

A clinical study evaluating PulseNmore MC™ for Hemodialysis Patients. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 19, 2025
Enrollment StartDec 15, 2022
Primary CompletionJun 1, 2023
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 1.0 years ago

Interventions

PulseNmore MC™device

novel mobile Self-scan ultrasound device, Pulsenmore MC™