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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NanoPass Technologies Ltd
ClinicalTrials.gov Identifier:
NCT00539084
First received: October 2, 2007
Last updated: May 8, 2013
Last verified: November 2007
  Purpose

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.


Condition Intervention
Local Anesthesia
Intradermal Injections
Device: MicronJet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Comparative Pilot Study to Assess the Safety and Efficacy of the MicronJet Microneedle Device Following Intradermal Injection of Lidocaine for Local Anesthesia

Resource links provided by NLM:


Further study details as provided by NanoPass Technologies Ltd:

Primary Outcome Measures:
  • Prevalence and intensity of adverse events [ Time Frame: 3 Days ] [ Designated as safety issue: No ]
  • Pain scores reported by the subjects following the painful stimulus [ Time Frame: one minute after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires [ Time Frame: 2 days after injection ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intradermal injection of Lidocaine followed by a painful stimulus (venipuncture)
Device: 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.
Placebo Comparator: 2
Intradermal injection of placebo followed by a painful stimulus (venipuncture)
Device: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539084

Sponsors and Collaborators
NanoPass Technologies Ltd
Investigators
Principal Investigator: Jacob Atsmon, MD Head of the unit for Clinical Research at the Sourasky Medical Center, Tel Aviv, Israel
  More Information

No publications provided

Responsible Party: NanoPass Technologies Ltd
ClinicalTrials.gov Identifier: NCT00539084     History of Changes
Other Study ID Numbers: NP40
Study First Received: October 2, 2007
Last Updated: May 8, 2013
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by NanoPass Technologies Ltd:
microneedles
microneedle
intradermal

Additional relevant MeSH terms:
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014