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

NCT ID: NCT00539084

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2007-11-30

Brief Summary

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

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.

Conditions

Local Anesthesia; Intradermal Injections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Intradermal injection of Lidocaine followed by a painful stimulus (venipuncture)

Group Type: EXPERIMENTAL

MicronJet

Intervention Type: DEVICE

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.

2

Intradermal injection of placebo followed by a painful stimulus (venipuncture)

Group Type: PLACEBO_COMPARATOR

MicronJet

Intervention Type: DEVICE

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.

Interventions

MicronJet

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NanoPass Technologies Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Atsmon, MD

Role: PRINCIPAL_INVESTIGATOR

Head of the unit for Clinical Research at the Sourasky Medical Center, Tel Aviv, Israel

Other Identifiers

NP40

Identifier Type: -

Identifier Source: org_study_id