HealthyPhase 1/2NCT01152983
Safety and Performance Evaluation of the Rapid Ring Device
A Phase 1/2 study testing Rapid Ring in people with Healthy, run by RapiDx Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rapid Ring
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Nov 2010
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is healthy
- Subject's age is between 18 to 70 years old
- Subject must be capable of providing informed consent
Who cannot join
- Clotting disorders
- Subject has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
- Subject is taking anti-coagulant medication
- Non-intact finger tip (left middle/ring finger)
- Skin disease on the subject finger
- Abnormal blood pressure
Show all 13Show fewer
- Pregnant or lactating women
- Menstrual period
- Previous diagnosis of HIV or Hepatitis
- Participation in other clinical investigations within previous 30 days
- Peripheral blood vessels diseases
- Diabetes
- Neuropathic pain
Trial locations and contacts
1 site in 1 country.
Boris Tartakovsky, PhD contact
Israel1 site
Tel-Aviv Sourasky Medical Center
Tel Aviv
Boris Tartakovsky, PhD, boris.tartakovsky@gmail.com
Ella Naparstek, Prof.
About this study
Official title: Single Center, Open Label, Prospective, Non-comparative, Non-randomized Study to Assess the Safety and Performance of the Rapid Ring Device (Comparative Study to Assess the Pain Reduction)
The purpose of this study is to demonstrate the safety, performance and initial efficacy of the RapiDx device.
Read the detailed description
The study will be a single center, open label, prospective, non-comparative, randomized trial and assess the safety and performance of the Rapid Ring device. In order to assess pain reduction, a comparative study will be performed and each subject will serve as his/her own control.
Clinical assessment for all 100% patients will occur at baseline. All participants will be men and women above the age of 18. The trial will be conducted at a Medical Center.
- Conditions
- Healthy
- Being tested
- Rapid Ring
- Keywords
- Finger sticks, Rapid Ring, Finger sticks method of obtaining blood for diagnostic testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid RingDevice
Rapid Ring is a ring-shaped device that encircles the distal phalanx of the middle finger and blocks the arterial blood to quickly and passively withdraw blood following a finger stick, and to reduce the pain of the lancet.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of at least 2 drops (approximately 50microliter) of blood within one minute.
Measured: approximately 6 months
Secondary outcomes (1)
Reduction in pain
Measured: approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RapiDx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ella Naparstek, Prof., Principal investigator, Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152983
- Sponsor's protocol ID
- CTIL - CL-001
- Status last verified
- Jun 2010
- First submitted
- 27 Jun 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open Label, Prospective, Non-comparative, Non-randomized Study to Assess the Safety and Performance of the Rapid Ring Device (Comparative Study to Assess the Pain Reduction)
- ClinicalTrials.gov ID
- NCT01152983
- Acronym / sponsor ID
- CTIL - CL-001
- Conditions
- Healthy
- Keywords
- Finger sticks, Rapid Ring, Finger sticks method of obtaining blood for diagnostic testing
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RapiDx Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 29 Jun 2010 (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 demonstrate the safety, performance and initial efficacy of the RapiDx device.
Detailed description
The study will be a single center, open label, prospective, non-comparative, randomized trial and assess the safety and performance of the Rapid Ring device. In order to assess pain reduction, a comparative study will be performed and each subject will serve as his/her own control.
Clinical assessment for all 100% patients will occur at baseline. All participants will be men and women above the age of 18. The trial will be conducted at a Medical Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is healthy
- Subject's age is between 18 to 70 years old
- Subject must be capable of providing informed consent
Key exclusion criteria (13 listed)
- Clotting disorders
- Subject has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
- Subject is taking anti-coagulant medication
- Non-intact finger tip (left middle/ring finger)
- Skin disease on the subject finger
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 |
|---|---|---|
| Rapid RingRapid Ring is a ring-shaped device that encircles the distal phalanx of the middle finger and blocks the arterial blood to quickly and passively withdraw blood following a finger stick, and to reduce the pain of the lancet. | Device | – |
Primary outcome
Collection of at least 2 drops (approximately 50microliter) of blood within one minute.
Time frame: approximately 6 months
1 secondary outcome
Reduction in pain
Time frame: approximately 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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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.
Boris Tartakovsky, PhD contact
Ella Naparstek, Prof. principal investigator
Chairman of the Hematology Institute and the Department of Hematology and Bone Marrow Transplantation at Tel Aviv Sourasky Medical Center.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rapid Ring in people with Healthy, run by RapiDx Ltd. at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Tartakovsky, PhD (boris.tartakovsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of at least 2 drops (approximately 50microliter) of blood within one minute. (time frame: approximately 6 months). 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 29 Jun 2010.