PainPhase 1NCT00746915
Phase I Study Evaluating The Safety And Efficacy of a Device for Collection of Electrical Bioimpedance Data
A Phase 1 study testing EpiDetect in people with Pain, run by ImpediGuide Ltd at 1 site in Israel.
Trial summary
The objectives of this study are to evaluate the safety and initial efficacy of the epidural injection procedure when combined with real-time multi-frequency bio-impedance measurements that collect data on the electrical bioimpedance characteristics of living human tissue on the path of the epidural needle. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- EpiDetect
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Jul 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or females 18 - 60 years of age
- Imaging spine study (CT or MRI) in previous 3 months.
- American Society of Anesthesiologists (ASA) class I-III
- Patients undergoing elective standard pain relief treatment of Epidural Steroid Injection
- Patients must be willing to participate in the study, and provide written informed consent
- Women of child bearing potential must have a negative pregnancy test during the screening and baseline visits or the patient must be surgically sterile or be at least one year postmenopausal
- Women of child-bearing potential must be using a medically acceptable method of birth control throughout the study such as: bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive that has been taken for at least three months, which the subject agrees to continue using during the study, or a double-barrier method which must consist of a combination of any two of the following: diaphragm, cervical cap, condom or spermicide.
Who cannot join
- Any contraindications for epidural injection
- Patient with severe scoliosis
- Previous spinal surgery, or any additional surgical intervention in the level of epidural injection other than elective standard pain relief treatment of Epidural Steroid Injection.
- Documented, known or per examination neurological deficiency in lower extremities.
- Pregnant or breastfeeding patients
- Patients who have participated in another study within 30 days of enrolment
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- Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study i.e. known coagulopathy or recent use of anticoagulants or anti aggregates.
- Presence of fever, sepsis or infection near the point of insertion or an infection in the bloodstream which may "seed" onto the catheter
- Patients with known Hypovolemia
- Any known Anatomical abnormalities, such as spina bifida, meningomyelocele or scoliosis
- Patient suffering problems of the central nervous system, including multiple sclerosis or syringomyelia
- Patients with identified heart-valve problems
- Patients excessively hirsute where the surface electrodes are to be placed that are unwilling to shave these areas.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization, Ein Kerem
Jerusalem
Elyad Davidson, Dr, (+972)-2-6776911, edavidson@hadassah.org.il
Elyda Davidson, Dr
About this study
Official title: A Prospective, Single-Center, Phase I Study Evaluating the Safety and Initial Efficacy of the Epidetect Device for Collection of Bioimpedance Data of Human Tissues in Patients Undergoing Elective Pain Relief Treatment of Lumbar Epidural Steroid Injection Under Fluoroscopy
The objectives of this study are to evaluate the safety and initial efficacy of the epidural injection procedure when combined with real-time multi-frequency bio-impedance measurements that collect data on the electrical bioimpedance characteristics of living human tissue on the path of the epidural needle.
- Conditions
- Pain
- Being tested
- EpiDetect
- Keywords
- Patients undergoing elective pain relief treatment of lumbar epidural steroid injection under fluoroscopy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiDetectDevice
During the epidural needle insertion, data will be collected to characterize in real-time the electrical bioimpedance properties of the types of tissue along the path of the needle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables collected will include the incidence of adverse events presented by severity, by seriousness and by relationship to study treatment
Measured: 2 weeks and 1 month post op
Secondary outcomes (1)
Obtaining real-time bioimpedance measurements in multiple frequencies within the range of 1kHz to 500kHz from human tissues crossed in the epidural needle path.
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImpediGuide Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elyad Davidson, Dr., Principal investigator, Hadassah Medical Oeganization, Ein Kerem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746915
- Sponsor's protocol ID
- IG-CA001-IS
- Status last verified
- Jun 2009
- First submitted
- 3 Sep 2008
- Last updated
- 5 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Phase I Study Evaluating the Safety and Initial Efficacy of the Epidetect Device for Collection of Bioimpedance Data of Human Tissues in Patients Undergoing Elective Pain Relief Treatment of Lumbar Epidural Steroid Injection Under Fluoroscopy
- ClinicalTrials.gov ID
- NCT00746915
- Acronym / sponsor ID
- IG-CA001-IS
- Conditions
- Pain
- Keywords
- Patients undergoing elective pain relief treatment of lumbar epidural steroid injection under fluoroscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ImpediGuide LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 4 Sep 2008 (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 objectives of this study are to evaluate the safety and initial efficacy of the epidural injection procedure when combined with real-time multi-frequency bio-impedance measurements that collect data on the electrical bioimpedance characteristics of living human tissue on the path of the epidural needle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or females 18 - 60 years of age
- Imaging spine study (CT or MRI) in previous 3 months.
- American Society of Anesthesiologists (ASA) class I-III
- Patients undergoing elective standard pain relief treatment of Epidural Steroid Injection
- Patients must be willing to participate in the study, and provide written informed consent
Key exclusion criteria (13 listed)
- Any contraindications for epidural injection
- Patient with severe scoliosis
- Previous spinal surgery, or any additional surgical intervention in the level of epidural injection other than elective standard pain relief treatment of Epidural Steroid Injection.
- Documented, known or per examination neurological deficiency in lower extremities.
- Pregnant or breastfeeding patients
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 |
|---|---|---|
| EpiDetectDuring the epidural needle insertion, data will be collected to characterize in real-time the electrical bioimpedance properties of the types of tissue along the path of the needle. | Device | – |
Primary outcome
Safety variables collected will include the incidence of adverse events presented by severity, by seriousness and by relationship to study treatment
Time frame: 2 weeks and 1 month post op
1 secondary outcome
Obtaining real-time bioimpedance measurements in multiple frequencies within the range of 1kHz to 500kHz from human tissues crossed in the epidural needle path.
Time frame: Day of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2009.
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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.
Elyad Davidson, Dr. principal investigator
Hadassah Medical Oeganization, Ein Kerem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EpiDetect in people with Pain, run by ImpediGuide 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 7 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 5 Jun 2009. 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 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.
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 Elyad Davidson, Dr. ((+972)-2-6776911, edavidson@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety variables collected will include the incidence of adverse events presented by severity, by seriousness and by relationship to study treatment (time frame: 2 weeks and 1 month post op). 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 5 Jun 2009.