HealthySOUNDDNCT07615959
Medicsen Smartpatch: Safety & Performance (SOUNDD)
A study testing Medicsen Smartpatch and Subcutaneous (SC) single dose in people with Healthy, run by Medicsensors S.L at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Medicsen Smartpatch and Subcutaneous (SC) single dose
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Medicsen Smartpatch, Subcutaneous (SC) single dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicsen SmartpatchDevice
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.
Subcutaneous (SC) single doseDevice
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector
| Study group | Role | What they receive |
|---|---|---|
| Sonophoresis | Experimental | In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability. Receives: Device: Medicsen Smartpatch |
| Subcutaneous injection | Active comparator | In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection. Receives: Device: Subcutaneous (SC) single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 - Device-related adverse events (adverse device effects; ADEs)
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.
Measured: Periprocedural
Stage 1 - Assessment of local tolerability through questionnaires and visual examination
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.
Measured: Periprocedural
Stage 2 - Area under the curve (AUC0-∞ and AUC0-t)
Primary Outcome Measure of Stage 2
Measured: 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)
Primary Outcome Measure of Stage 2
Measured: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Secondary outcomes (13)
Stage 1 - Peak plasma concentration (Cmax)
Secondary Outcome Measure of Stage 1.
Measured: 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)
Secondary Outcome Measure of Stage 1.
Measured: 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
Secondary Outcome Measure of Stage 1.
Measured: 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.
Secondary Outcome Measure of Stage 1.
Measured: Periprocedural
Stage 2 - Tmax and t1/2
Secondary Outcome Measure of Stage 2.
Measured: 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
Secondary Outcome Measure of Stage 2.
Measured: Periprocedural
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in laboratory parameters (hematology and biochemistry)
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
Measured: Through study completion
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in vital signs.
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
Measured: Through study completion
Stage 2 - Number of participants with changes in electrocardiogram from baseline
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.
Measured: Through study completion
Stage 2 - Assessment of local tolerability through questionnaires and visual examination
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.
Measured: Periprocedural
Stage 2 - Time at which the device notifies that the full dose has been delivered.
Secondary Outcome Measure of Stage 2
Measured: Periprocedural
Stage 2 - Usability endpoints (for healthcare professionals)
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.
Measured: Immediately after the intervention
Stage 2 - Usability endpoints (for patients)
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.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start20 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicsensors S.L
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SmartBIO Analytics, Hospital Universitario Ramon y Cajal, Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615959
- Sponsor's protocol ID
- MSP-001
- Acronym
- SOUNDD
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mannocci A, De Carli G, Di Bari V, Saulle R, Unim B, Nicolotti N, Carbonari L, Puro V, La Torre G. How Much do Needlestick Injuries Cost? A Systematic Review of the Economic Evaluations of Needlestick and Sharps Injuries Among Healthcare Personnel. Infect Control Hosp Epidemiol. 2016 Jun;37(6):635-46. doi: 10.1017/ice.2016.48. Epub 2016 Mar 29.
PubMed 27022671Elder A, Paterson C. Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices. Occup Med (Lond). 2006 Dec;56(8):566-74. doi: 10.1093/occmed/kql122. Epub 2006 Oct 25.
PubMed 17065314Aronson R. The role of comfort and discomfort in insulin therapy. Diabetes Technol Ther. 2012 Aug;14(8):741-7. doi: 10.1089/dia.2012.0038. Epub 2012 Apr 26.
PubMed 22537418Wagner J, Malchoff C, Abbott G. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes. Diabetes Technol Ther. 2005 Aug;7(4):612-9. doi: 10.1089/dia.2005.7.612.
PubMed 16120035Jenkins K. II. Needle phobia: a psychological perspective. Br J Anaesth. 2014 Jul;113(1):4-6. doi: 10.1093/bja/aeu013. Epub 2014 Feb 25. No abstract available.
PubMed 24574504McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.
PubMed 30109720Schoellhammer CM, Polat BE, Mendenhall J, Maa R, Jones B, Hart DP, Langer R, Blankschtein D. Rapid skin permeabilization by the simultaneous application of dual-frequency, high-intensity ultrasound. J Control Release. 2012 Oct 28;163(2):154-60. doi: 10.1016/j.jconrel.2012.08.019. Epub 2012 Aug 23.
PubMed 22940128Barati AH, Mokhtari-Dizaji M, Mozdarani H, Bathaie Z, Hassan ZM. Effect of exposure parameters on cavitation induced by low-level dual-frequency ultrasound. Ultrason Sonochem. 2007 Sep;14(6):783-9. doi: 10.1016/j.ultsonch.2006.12.016. Epub 2007 Jan 23.
PubMed 17347019Tezel A, Sens A, Mitragotri S. Investigations of the role of cavitation in low-frequency sonophoresis using acoustic spectroscopy. J Pharm Sci. 2002 Feb;91(2):444-53. doi: 10.1002/jps.10024.
PubMed 11835204Mitragotri S, Blankschtein D, Langer R. Ultrasound-mediated transdermal protein delivery. Science. 1995 Aug 11;269(5225):850-3. doi: 10.1126/science.7638603.
PubMed 7638603Tachibana K. Transdermal delivery of insulin to alloxan-diabetic rabbits by ultrasound exposure. Pharm Res. 1992 Jul;9(7):952-4. doi: 10.1023/a:1015869420159. No abstract available.
PubMed 1438012Tachibana K, Tachibana S. Transdermal delivery of insulin by ultrasonic vibration. J Pharm Pharmacol. 1991 Apr;43(4):270-1. doi: 10.1111/j.2042-7158.1991.tb06681.x.
PubMed 1676740Williams AR. Phonophoresis: an in vivo evaluation using three topical anaesthetic preparations. Ultrasonics. 1990 May;28(3):137-41. doi: 10.1016/0041-624x(90)90075-y.
PubMed 2339470Levy D, Kost J, Meshulam Y, Langer R. Effect of ultrasound on transdermal drug delivery to rats and guinea pigs. J Clin Invest. 1989 Jun;83(6):2074-8. doi: 10.1172/JCI114119.
PubMed 2498396Bommannan D, Okuyama H, Stauffer P, Guy RH. Sonophoresis. I. The use of high-frequency ultrasound to enhance transdermal drug delivery. Pharm Res. 1992 Apr;9(4):559-64. doi: 10.1023/a:1015808917491.
PubMed 1495903
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Safety, Tolerability and Performance of the Medicsen Smartpatch, a Non-Invasive Ultrasound-Based Drug Delivery Medical Device (SOUNDD Study)
- ClinicalTrials.gov ID
- NCT07615959
- Acronym / sponsor ID
- SOUNDD / MSP-001
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medicsensors S.LIndustry (pharma, biotech, devices)
- Collaborators
- SmartBIO Analytics, Hospital Universitario Ramon y Cajal, Avania
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonophoresis | Experimental | Device: Medicsen SmartpatchIn the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability. |
| Subcutaneous injection | Active comparator | Device: Subcutaneous (SC) single doseIn the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicsen SmartpatchThis 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. | Device | Sonophoresis |
| Subcutaneous (SC) single doseThis intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector | Device | Subcutaneous injection |
Primary outcome
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.
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.
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
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
13 secondary outcomes
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
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
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
Stage 1 - Time at which the device notifies that the full dose has been delivered.
Time frame: 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
Stage 2 - Incidence and severity of ADEs
Time frame: Periprocedural
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in laboratory parameters (hematology and biochemistry)
Time frame: Through study completion
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in vital signs.
Time frame: Through study completion
Stage 2 - Number of participants with changes in electrocardiogram from baseline
Time frame: Through study completion
Stage 2 - Assessment of local tolerability through questionnaires and visual examination
Time frame: Periprocedural
Stage 2 - Time at which the device notifies that the full dose has been delivered.
Time frame: Periprocedural
Stage 2 - Usability endpoints (for healthcare professionals)
Time frame: Immediately after the intervention
Stage 2 - Usability endpoints (for patients)
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 27022671Mannocci A, De Carli G, Di Bari V, Saulle R, Unim B, Nicolotti N, Carbonari L, Puro V, La Torre G. How Much do Needlestick Injuries Cost? A Systematic Review of the Economic Evaluations of Needlestick and Sharps Injuries Among Healthcare Personnel. Infect Control Hosp Epidemiol. 2016 Jun;37(6):635-46. doi: 10.1017/ice.2016.48. Epub 2016 Mar 29.
- Background: PubMed 17065314Elder A, Paterson C. Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices. Occup Med (Lond). 2006 Dec;56(8):566-74. doi: 10.1093/occmed/kql122. Epub 2006 Oct 25.
- Background: PubMed 22537418Aronson R. The role of comfort and discomfort in insulin therapy. Diabetes Technol Ther. 2012 Aug;14(8):741-7. doi: 10.1089/dia.2012.0038. Epub 2012 Apr 26.
- Background: PubMed 16120035Wagner J, Malchoff C, Abbott G. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes. Diabetes Technol Ther. 2005 Aug;7(4):612-9. doi: 10.1089/dia.2005.7.612.
- Background: PubMed 24574504Jenkins K. II. Needle phobia: a psychological perspective. Br J Anaesth. 2014 Jul;113(1):4-6. doi: 10.1093/bja/aeu013. Epub 2014 Feb 25. No abstract available.
- Background: PubMed 30109720McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.
- Background: PubMed 22940128Schoellhammer CM, Polat BE, Mendenhall J, Maa R, Jones B, Hart DP, Langer R, Blankschtein D. Rapid skin permeabilization by the simultaneous application of dual-frequency, high-intensity ultrasound. J Control Release. 2012 Oct 28;163(2):154-60. doi: 10.1016/j.jconrel.2012.08.019. Epub 2012 Aug 23.
- Background: PubMed 17347019Barati AH, Mokhtari-Dizaji M, Mozdarani H, Bathaie Z, Hassan ZM. Effect of exposure parameters on cavitation induced by low-level dual-frequency ultrasound. Ultrason Sonochem. 2007 Sep;14(6):783-9. doi: 10.1016/j.ultsonch.2006.12.016. Epub 2007 Jan 23.
- Background: PubMed 11835204Tezel A, Sens A, Mitragotri S. Investigations of the role of cavitation in low-frequency sonophoresis using acoustic spectroscopy. J Pharm Sci. 2002 Feb;91(2):444-53. doi: 10.1002/jps.10024.
- Background: PubMed 7638603Mitragotri S, Blankschtein D, Langer R. Ultrasound-mediated transdermal protein delivery. Science. 1995 Aug 11;269(5225):850-3. doi: 10.1126/science.7638603.
- Background: PubMed 1438012Tachibana K. Transdermal delivery of insulin to alloxan-diabetic rabbits by ultrasound exposure. Pharm Res. 1992 Jul;9(7):952-4. doi: 10.1023/a:1015869420159. No abstract available.
- Background: PubMed 1676740Tachibana K, Tachibana S. Transdermal delivery of insulin by ultrasonic vibration. J Pharm Pharmacol. 1991 Apr;43(4):270-1. doi: 10.1111/j.2042-7158.1991.tb06681.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medicsen Smartpatch and Subcutaneous (SC) single dose in people with Healthy, run by Medicsensors S.L at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1 - Device-related adverse events (adverse device effects; ADEs) (time frame: Periprocedural). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07615959, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.