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

25 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Spagna
    • Madrid
      • Madrid, Madrid, Spagna, 28034
        • Hospital Universitario Ramon y Cajal

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sonophoresis
In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability.
Dispositivo: 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.
Comparatore attivo: Subcutaneous injection
In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection.
Dispositivo: Subcutaneous (SC) single dose
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stage 1 - Device-related adverse events (adverse device effects; ADEs)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Stage 1 - Peak plasma concentration (Cmax)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: Periprocedural
Secondary Outcome Measure of Stage 1.
Periprocedural
Stage 2 - Tmax and t1/2
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: Periprocedural
Secondary Outcome Measure of Stage 2
Periprocedural
Stage 2 - Usability endpoints (for healthcare professionals)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medicsensors S.L

Collaboratori

Hospital Universitario Ramon y Cajal
Avania
SmartBIO Analytics

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 gennaio 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

30 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MSP-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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