A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the MicronJet microneedle device is effective for inducing rapid and painless local anesthesia prior to insertions of intravenous catheters.

Detailed Description
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Local anesthesia is routinely administered to reduce patient discomfort and improve the outcome of a wide variety of painful medical procedures. However, injection of a local anesthetic agent into the skin using a regular needle is in itself painful. Therefore, common procedures involving needle pricks (e.g. venipuncture) which may be quite painful are usually performed without local anesthesia. NanoPass has developed a microneedle injection device (MicronJet) which enables painless delivery of drugs directly into the superficial layers of the skin. The objective of the study is to assess the safety and efficacy of this device for intradermal injection of a local anesthetic agent before insertion of an intravenous catheter to healthy adults. Each subject will receive an injection of a local anesthetic to one arm, and a control placebo injection of physiological water to the other arm. Both injections will be administered intradermally using the MicronJet. Following the injections, an intravenous catheter will be inserted into the injection site in each arm, and the subject will rate the pain caused by the insertion. Safety parameters will be recorded throughout the study.

Official Title
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A Controlled Comparative Pilot Study to Assess the Safety and Efficacy of the MicronJet Microneedle Device Following Intradermal Injection of Lidocaine for Local Anesthesia

Conditions
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Local Anesthesia, Intradermal Injections

Intervention / Treatment
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* Device: MicronJet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females. a signed informed consent. No significant abnormalities in screening physical exam. No significant abnormalities in clinical laboratory parameters. No significant abnormalities in ECG within 21 days of the start of the study. Intact skin at the sites of injection. Accessible veins in the antecubital area. Exclusion Criteria: Hypersensitivity to local anaesthetics. History of previous vasovagal events. Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions at the injection sites. Subjects with active or chronic skin disease or systemic disease with significant skin involvement. History of skin allergy or hypersensitivity. History of easy bruising. Current or previous history of neurological disorders (particularly neuropathies). A history of drug or alcohol abuse. Acute infection within 7 days prior to study day. Subjects who participated in a clinical study within 4 weeks prior to study day, or who plan to participate in another clinical trial during the time of the trial. Subjects suffering from Behçet's disease. Pregnant or lactating women. Any contraindication (relative or absolute) to study drug.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intradermal injection of Lidocaine followed by a painful stimulus (venipuncture) | Device: MicronJet<br>* The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.<br>|
| Placebo Comparator: 2<br>Intradermal injection of placebo followed by a painful stimulus (venipuncture) | Device: MicronJet<br>* The MicronJet is a microneedle injection device designed for intradermal delivery of drugs (i.e. delivery into the layers of the skin). In this study the MicronJet will be used to inject Lidocaine or Saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and intensity of adverse events |  | 3 Days | 
| Pain scores reported by the subjects following the painful stimulus |  | one minute after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires |  | 2 days after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microneedles, microneedle, intradermal