Medicsen Smartpatch: Safety & Performance (SOUNDD) (SOUNDD)

May 25, 2026 updated by: Medicsensors S.L

Clinical Investigation to Evaluate the Safety, Tolerability and Performance of the Medicsen Smartpatch, a Non-Invasive Ultrasound-Based Drug Delivery Medical Device (SOUNDD Study)

The goal of this clinical trial is to understand the efficacy of Medicsen's Smartpatch to deliver drugs through the skin in healthy volunteers. The main questions it aims to answer are:

  • Is the administration with Medicsen Smartpatch safe for the patient?
  • Can Medicsen's Smartpatch be used to effectively administer drugs to patients?

Researchers will compare administration with Medicsen's Smartpatch with the subcutaneous administration of the drug to see if the efficacy and safety are comparable

Participants will be asked to fill a tolerability survey after receiving each of the two interventions: Subcutaneous administration and Medicse's Smartpatch.

Blood samples will be taken at different timepoints to asses for efficacy of each treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The clinical investigation will be conducted in two stages:

Stage 1: A first-in-human pilot study to evaluate the safety, tolerability, and exploratory performance of the Medicsen Smartpatch for drug delivery in healthy volunteers: a single-center, open-label study.

Stage 2: A confirmatory study to evaluate the performance of the Medicsen Smartpatch by comparing sonophoresis with subcutaneous drug delivery: a randomized, single-dose, open-label, two-way crossover study in healthy volunteers.

Study subjects will be monitored for device-attributable adverse effects during the scheduled examinations and at any examinations resulting from study subjects' self-reported concerns. A licensed physician will review any unanticipated adverse events associated with the protocol.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subjects must provide signed informed consent prior to participation in any study related procedures
  • Healthy Caucasian volunteers, any sex, aged between 18 to 55 years
  • Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
  • Ability and agreement to comply with the study requirements
  • Medical history and physical examination within normal limits.
  • No clinically relevant abnormalities in hematology, biochemistry, virology, or urine tests.
  • Participants who engage in sexual activity which could result in pregnancy for themselves or their partner(s) must agree to use highly effective methods of contraception during the clinical investigation.

Exclusion Criteria:

  • Case history of hypersensitivity to medicinal products or any other allergic process that could interfere with study according to the investigator's judgement.
  • Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, dermatology, gastrointestinal distress, hypertension, or infectious acute processes that could interfere with study according to the investigator's judgement.
  • Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgement.
  • Administration of topic or systemic medication including medicinal plants within 14 days before the intervention.
  • Presence of skin disorders or lesions at the intended application site (e.g., eczema, psoriasis, infections, open wounds), which may interfere with drug absorption or increase risk of adverse effects.
  • Implanted electronic medical devices, such as pacemakers or neurostimulators, due to potential interference with ultrasonic energy.
  • Pregnant or breastfeeding women, due to lack of safety data for either the drug or the ultrasound application in this population.
  • Severe cognitive or motor impairment, where safe operation of the patch cannot be ensured, unless under continuous caregiver supervision.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sonophoresis
In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability.
Device: Medicsen Smartpatch
This intervention consists of administering the drug using the Medicsen Smartpatch, a non-invasive, needle-free drug delivery device that utilizes sonophoresis technology to enhance absorption through the skin.
Active Comparator: Subcutaneous injection
In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection.
Device: Subcutaneous (SC) single dose
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage 1 - Device-related adverse events (adverse device effects; ADEs)
Time Frame: Periprocedural

Primary Outcome Measure of Stage 1.

Incidence and severity of ADEs is assesed, with special focus on those occurred at the site of administration and those leading to treatment interruption.
Periprocedural
Stage 1 - Assessment of local tolerability through questionnaires and visual examination
Time Frame: Periprocedural

Primary Outcome Measure of Stage 1.

Subject-reported sensations (pain/burning, itching/stinging, discomfort) during and after administration are assesed through questionnaires.

Dermatologist-evaluated skin signs (erythema, edema, vesicles, crusts/exudate, scaling/lichenification, hematomas/bleeding, tenderness) are assesed through visual examination.
Periprocedural
Stage 2 - Area under the curve (AUC0-∞ and AUC0-t)
Time Frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Primary Outcome Measure of Stage 2
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 2 - Peak plasma concentration (Cmax)
Time Frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Primary Outcome Measure of Stage 2
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage 1 - Peak plasma concentration (Cmax)
Time Frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Secondary Outcome Measure of Stage 1.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 1 -Area under the curve (AUC0-∞ and AUC0-t)
Time Frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Secondary Outcome Measure of Stage 1.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 1 - Tmax and t1/2
Time Frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Secondary Outcome Measure of Stage 1.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 1 - Time at which the device notifies that the full dose has been delivered.
Time Frame: Periprocedural
Secondary Outcome Measure of Stage 1.
Periprocedural
Stage 2 - Tmax and t1/2
Time Frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Secondary Outcome Measure of Stage 2.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 2 - Incidence and severity of ADEs
Time Frame: Periprocedural
Secondary Outcome Measure of Stage 2.
Periprocedural
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in laboratory parameters (hematology and biochemistry)
Time Frame: Through study completion

Secondary Outcome Measure of Stage 2.

Number of participants with laboratory values outside the normal reference range that are considered clinically significant compared to baseline. This includes hematology (hemoglobin, hematocrit, Red blood cell, MCV, MCH, MCHC, White blood cell with differential, and platelets) and biochemistry (urea, creatinine, glucose, AST (SGOT), ALT (SGPT), GGT, ALP, and total bilirubin).

Unit of measure: Participants
Through study completion
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in vital signs.
Time Frame: Through study completion

Secondary Outcome Measure of Stage 2.

Number of participants with vital sign values outside the normal reference range that are considered clinically significant compared to baseline. This includes Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart Rate (HR), Respiratory Rate (RR), and Temperature (T) measured before and after the procedure.

Unit of measure: Participants
Through study completion
Stage 2 - Number of participants with changes in electrocardiogram from baseline
Time Frame: Through study completion

Secondary Outcome Measure of Stage 2.

A standard 12-lead ECG is performed with an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals before and after the procedure to determine changes from baseline values.
Through study completion
Stage 2 - Assessment of local tolerability through questionnaires and visual examination
Time Frame: Periprocedural

Secondary Outcome Measure of Stage 2.

Subject-reported sensations (pain/burning, itching/stinging, discomfort) during and after administration of both interventions are assesed through questionnaires.

Dermatologist- evaluated skin signs (erythema, edema, vesicles, crusts/exudate, scaling/lichenification, hematomas/bleeding, tenderness) after Medicsen Smartpatch intervention are assesed through visual examination.
Periprocedural
Stage 2 - Time at which the device notifies that the full dose has been delivered.
Time Frame: Periprocedural
Secondary Outcome Measure of Stage 2
Periprocedural
Stage 2 - Usability endpoints (for healthcare professionals)
Time Frame: Immediately after the intervention

Secondary Outcome Measure of Stage 2.

Rate of first-attempt success, time to complete setup, clarity of instructions, and user-reported ease-of-use scores for healthcare professionals are assesed through the Healthcare Proffesionals' Usability Questionnaire, in which a score from 1 to 5 is given to each of the measurements, and where a higher score means a worse outcome.
Immediately after the intervention
Stage 2 - Usability endpoints (for patients)
Time Frame: Immediately after the intervention

Secondary Outcome Measure of Stage 2.

Comfort and willingness to reuse the device are assesed through the Patient's Usability Questionnaire, in which a score from 1 to 5 is given to each of the measures, and where a higher score means a worse outcome.
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicsensors S.L

Collaborators

Hospital Universitario Ramon y Cajal
Avania
SmartBIO Analytics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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