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

NCT00539084 | Completed

• 1 other identifier: NP40
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Local Anesthesia; Intradermal Injections

Keywords

microneedles; microneedle; intradermal

Outcome Measures

Primary Outcomes (2)

• Prevalence and intensity of adverse events

  3 Days

• Pain scores reported by the subjects following the painful stimulus

  one minute after injection

Secondary Outcomes (1)

• Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires

  2 days after injection

Study Arms (2)

1

EXPERIMENTAL

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

Device: MicronJet

2

PLACEBO COMPARATOR

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

Device: MicronJet

Interventions

MicronJet 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.

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NanoPass Technologies Ltd: lead

Study Officials

• Jacob Atsmon, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 10, 2013

Record last verified: 2007-11