Local AnesthesiaNCT00539084
A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia
A study testing MicronJet in people with Local Anesthesia and Intradermal Injections, run by NanoPass Technologies Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia, Intradermal Injections
- What is being tested?
- MicronJet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
About this study
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
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.
Read the 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
- Being tested
- MicronJet
- Keywords
- microneedles, microneedle, intradermal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicronJetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intradermal injection of Lidocaine followed by a painful stimulus (venipuncture) Receives: Device: MicronJet |
| 2 | Placebo comparator | Intradermal injection of placebo followed by a painful stimulus (venipuncture) Receives: Device: MicronJet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and intensity of adverse events
Measured: 3 Days
Pain scores reported by the subjects following the painful stimulus
Measured: one minute after injection
Secondary outcomes (1)
Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires
Measured: 2 days after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local AnesthesiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoPass Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Atsmon, MD, Principal investigator, Head of the unit for Clinical Research at the Sourasky Medical Center, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00539084
- Sponsor's protocol ID
- NP40
- Status last verified
- Nov 2007
- First submitted
- 2 Oct 2007
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00539084
- Acronym / sponsor ID
- NP40
- Conditions
- Local Anesthesia, Intradermal Injections
- Keywords
- microneedles, microneedle, intradermal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NanoPass Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Oct 2007 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: MicronJetIntradermal injection of Lidocaine followed by a painful stimulus (venipuncture) |
| 2 | Placebo comparator | Device: MicronJetIntradermal injection of placebo followed by a painful stimulus (venipuncture) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| MicronJetThe 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. | Device | 1, 2 |
Primary outcome
Prevalence and intensity of adverse events
Time frame: 3 Days
Pain scores reported by the subjects following the painful stimulus
Time frame: one minute after injection
1 secondary outcome
Feedback from study participants and staff on their overall impression with the MicronJet device, using questionnaires
Time frame: 2 days after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
Related trials for Local Anesthesia
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
Jacob Atsmon, MD principal investigator
Head of the unit for Clinical Research at the Sourasky Medical Center, Tel Aviv, Israel
Questions about this trial
What is this clinical trial studying?
A study testing MicronJet in people with Local Anesthesia and Intradermal Injections, run by NanoPass Technologies Ltd.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence and intensity of adverse events (time frame: 3 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2013.