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

25. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

30

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Sonophoresis
In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability.
Přístroj: 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.
Aktivní komparátor: Subcutaneous injection
In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection.
Přístroj: Subcutaneous (SC) single dose
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Stage 1 - Device-related adverse events (adverse device effects; ADEs)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Stage 1 - Peak plasma concentration (Cmax)
Časové okno: 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)
Časové okno: 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
Časové okno: 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.
Časové okno: Periprocedural
Secondary Outcome Measure of Stage 1.
Periprocedural
Stage 2 - Tmax and t1/2
Časové okno: 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
Časové okno: 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)
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 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.
Časové okno: Periprocedural
Secondary Outcome Measure of Stage 2
Periprocedural
Stage 2 - Usability endpoints (for healthcare professionals)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Medicsensors S.L

Spolupracovníci

Hospital Universitario Ramon y Cajal
Avania
SmartBIO Analytics

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. ledna 2026

Primární dokončení (Odhadovaný)

1. listopadu 2026

Dokončení studie (Odhadovaný)

1. listopadu 2026

Termíny zápisu do studia

První předloženo

30. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

25. května 2026

První zveřejněno (Aktuální)

29. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

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produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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