Chronic PainNCT07654907
Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management
A study testing EpiFaith™ Syringe and Conventional Loss-of-Resistance Syringe in people with Chronic Pain, run by Flat Medical Co., Ltd at 2 sites in United States.
Trial summary
This study evaluates a new medical device called the EpiFaith™ Syringe, which is designed to help clinicians more accurately identify the epidural space during pain management procedures. The epidural space is a narrow area near the spine where medication is delivered to treat chronic pain conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- EpiFaith™ Syringe and Conventional Loss-of-Resistance Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 May 2026to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older at the time of informed consent.
- Scheduled to undergo a clinically indicated interventional pain management procedure as part of routine clinical care at the study site.
- Planned procedure requires epidural space localization using the loss-of-resistance technique and is compatible with use of either a conventional loss-of-resistance syringe or the EpiFaith™ syringe, in the judgment of the treating clinician.
- Eligible procedure types include cervical, thoracic, lumbar, or caudal epidural procedures; minimally invasive lumbar decompression (MILD) procedures when epidural access or localization is required; and spinal cord stimulation (SCS) trial epidural access procedures.
- Able and willing to provide written informed consent before any study-specific data collection.
- Able and willing to comply with post-procedure follow-up assessments through approximately 1 week after the procedure, including telephone or telehealth follow-up when applicable.
- For participants receiving anticoagulant or antiplatelet therapy, the treating clinician must determine that the participant can safely undergo the planned epidural procedure according to standard institutional practice and applicable neuraxial anticoagulation guidance.
Who cannot join
- Inability to provide written informed consent independently, including adults who require consent by a legally authorized representative.
- Known contraindication to the planned epidural procedure, including active infection at the puncture site, uncontrolled coagulopathy, or anticoagulant or antiplatelet status that precludes the planned procedure in the judgment of the treating clinician.
- Known hypersensitivity or contraindication to any standard-of-care medication, contrast agent, or procedural material required for the planned epidural procedure, where such contraindication precludes the procedure.
- Participation in another interventional clinical trial that, in the investigator's judgment, would confound interpretation of study endpoints.
- Any medical, anatomic, procedural, or clinical condition that, in the investigator's judgment, would make study participation unsafe or not in the participant's best interest.
- Pregnancy, unless the epidural procedure is clinically indicated and permitted under the enrolling site's standard clinical practice and IRB-approved procedures.
- Unwillingness or inability to complete required study assessments through approximately 1 week after the procedure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Innovative Pain Treatment Solutions
San Diego, California, 92111
Krishnan Chakravarthy, MD, PhD
Innovative Pain Treatment Solutions
Temecula, California, 92590
Krishnan Chakravarthy, MD, PhD
About this study
Official title: Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management: A Prospective, Open-Label, Non-Randomized Comparative Study Versus Conventional Loss-of-Resistance Technique
This study evaluates a new medical device called the EpiFaith™ Syringe, which is designed to help clinicians more accurately identify the epidural space during pain management procedures. The epidural space is a narrow area near the spine where medication is delivered to treat chronic pain conditions. Finding this space correctly is a critical step in procedures such as epidural steroid injections, spinal cord stimulator placement, and minimally invasive lumbar decompression (MILD).
Currently, clinicians locate the epidural space using a method called loss-of-resistance (LOR), which relies on the feel of a syringe plunger as a needle is advanced toward the epidural space. This technique depends on the clinician's experience and touch, and can sometimes result in multiple needle attempts or an incorrect signal that the epidural space has been reached when it has not.
Read more
The EpiFaith™ Syringe is designed to provide a clear visual signal, called the Faith Signal, at the moment the epidural space is entered, reducing reliance on touch alone. The device is used with standard epidural needles and does not require additional equipment or significant changes to routine procedure workflow.
This study will enroll 100 adults scheduled for a clinically indicated epidural pain procedure at Innovative Pain Treatment Solutions in Temecula or San Diego, California. Participants will be assigned to have their procedure performed using either the EpiFaith™ Syringe or a standard LOR syringe. The study will compare the number of needle attempts needed to access the epidural space and the rate of false signals between the two methods. Safety and patient-reported pain outcomes will also be collected for approximately one week following the procedure.
- Conditions
- Chronic Pain
- Being tested
- EpiFaith™ Syringe, Conventional Loss-of-Resistance Syringe
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiFaith™ SyringeDevice
The EpiFaith™ Syringe is a sterile, single-use piston syringe designed to assist clinicians in identifying the epidural space during neuraxial procedures. Unlike conventional loss-of-resistance syringes that rely solely on tactile feedback, the EpiFaith™ incorporates a spring-loaded piston mechanism that produces an objective visual indicator, the "Faith Signal," at the moment resistance decreases consistent with epidural space entry. The device is compatible with standard epidural needles and integrates into routine procedural workflow without significant modification.
Conventional Loss-of-Resistance SyringeDevice
Standard saline loss-of-resistance technique using a conventional epidural syringe. The clinician applies intermittent or continuous pressure to the syringe plunger while advancing the epidural needle, interpreting a sudden reduction in resistance as entry into the epidural space. No investigational device is used in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Conventional LOR Syringe | Active comparator | Standard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures Receives: Device: Conventional Loss-of-Resistance Syringe |
| EpiFaith™ Syringe | Experimental | EpiFaith™ syringe used in place of conventional LOR technique. Receives: Device: EpiFaith™ Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure number of attempts
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
Measured: Intra-procedure
Measure false loss-of-resistance
Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
Measured: Intra-procedure
Secondary outcomes (3)
Measure device related and procedure-related adverse events
Measure: Incidence, nature, and severity of device-related and procedure-related adverse events
Measured: Procedure day through approximately 1 week post-procedure
Change in pain intensity score on the 11-Point Numeric Rating Scale (NRS)
Pain intensity will be assessed using the 11-point Numeric Rating Scale for pain, scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Change from baseline will be calculated at each post-procedure follow-up time point. Negative change values indicate improvement, reflecting lower pain intensity compared with baseline.
Measured: Baseline before the procedure on Day 0 and approximately 3 hours, 24 hours, 48 hours, 72 hours, and 7 days after the procedure.
Clinician Usability Score on a 5-Point Likert Agreement Scale
Clinician usability and workflow integration will be assessed immediately after the procedure using a structured post-procedure questionnaire. The questionnaire evaluates ease of setup and preparation, clarity of the visual indicator, support for stable and controlled needle advancement, confidence in identifying the epidural space, integration into standard workflow, reduction in uncertainty compared with conventional loss-of-resistance technique, overall satisfaction, and willingness to use the device again for similar procedures. Each item is scored on a 5-point Likert agreement scale from 1 to 5, where 1 indicates strongly disagree, 3 indicates neutral, and 5 indicates strongly agree. Higher scores indicate better clinician-perceived usability, satisfaction, and workflow integration.
Measured: Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start28 May 2026 (estimated)
- Primary completion27 Sep 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flat Medical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maja Green, PhD, MBA, Study director, Solaris Research Institute IncKrishnan Chakravarthy, MD, PhD, Principal investigator, Solaris Research Institute Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654907
- Sponsor's protocol ID
- FM-EF-REG-001
- Other IDs
- 20261196
- Status last verified
- Jun 2026
- First submitted
- 24 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management: A Prospective, Open-Label, Non-Randomized Comparative Study Versus Conventional Loss-of-Resistance Technique
- ClinicalTrials.gov ID
- NCT07654907
- Acronym / sponsor ID
- FM-EF-REG-001
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Flat Medical Co., LtdUniversity, hospital or other
- Study start
- 28 May 2026 (estimated)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- 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.
This study evaluates a new medical device called the EpiFaith™ Syringe, which is designed to help clinicians more accurately identify the epidural space during pain management procedures. The epidural space is a narrow area near the spine where medication is delivered to treat chronic pain conditions. Finding this space correctly is a critical step in procedures such as epidural steroid injections, spinal cord stimulator placement, and minimally invasive lumbar decompression (MILD).
Currently, clinicians locate the epidural space using a method called loss-of-resistance (LOR), which relies on the feel of a syringe plunger as a needle is advanced toward the epidural space. This technique depends on the clinician's experience and touch, and can sometimes result in multiple needle attempts or an incorrect signal that the epidural space has been reached when it has not.
The EpiFaith™ Syringe is designed to provide a clear visual signal, called the Faith Signal, at the moment the epidural space is entered, reducing reliance on touch alone. The device is used with standard epidural needles and does not require additional equipment or significant changes to routine procedure workflow.
This study will enroll 100 adults scheduled for a clinically indicated epidural pain procedure at Innovative Pain Treatment Solutions in Temecula or San Diego, California. Participants will be assigned to have their procedure performed using either the EpiFaith™ Syringe or a standard LOR syringe. The study will compare the number of needle attempts needed to access the epidural space and the rate of false signals between the two methods. Safety and patient-reported pain outcomes will also be collected for approximately one week following the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional LOR Syringe | Active comparator | Device: Conventional Loss-of-Resistance SyringeStandard-of-care loss-of-resistance technique using a conventional syringe during epidural procedures |
| EpiFaith™ Syringe | Experimental | Device: EpiFaith™ SyringeEpiFaith™ syringe used in place of conventional LOR technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older at the time of informed consent.
- Scheduled to undergo a clinically indicated interventional pain management procedure as part of routine clinical care at the study site.
- Planned procedure requires epidural space localization using the loss-of-resistance technique and is compatible with use of either a conventional loss-of-resistance syringe or the EpiFaith™ syringe, in the judgment of the treating clinician.
- Eligible procedure types include cervical, thoracic, lumbar, or caudal epidural procedures; minimally invasive lumbar decompression (MILD) procedures when epidural access or localization is required; and spinal cord stimulation (SCS) trial epidural access procedures.
- Able and willing to provide written informed consent before any study-specific data collection.
Key exclusion criteria (7 listed)
- Inability to provide written informed consent independently, including adults who require consent by a legally authorized representative.
- Known contraindication to the planned epidural procedure, including active infection at the puncture site, uncontrolled coagulopathy, or anticoagulant or antiplatelet status that precludes the planned procedure in the judgment of the treating clinician.
- Known hypersensitivity or contraindication to any standard-of-care medication, contrast agent, or procedural material required for the planned epidural procedure, where such contraindication precludes the procedure.
- Participation in another interventional clinical trial that, in the investigator's judgment, would confound interpretation of study endpoints.
- Any medical, anatomic, procedural, or clinical condition that, in the investigator's judgment, would make study participation unsafe or not in the participant's best interest.
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 |
|---|---|---|
| EpiFaith™ SyringeThe EpiFaith™ Syringe is a sterile, single-use piston syringe designed to assist clinicians in identifying the epidural space during neuraxial procedures. Unlike conventional loss-of-resistance syringes that rely solely on tactile feedback, the EpiFaith™ incorporates a spring-loaded piston mechanism that produces an objective visual indicator, the "Faith Signal," at the moment resistance decreases consistent with epidural space entry. The device is compatible with standard epidural needles and integrates into routine procedural workflow without significant modification. | Device | EpiFaith™ Syringe |
| Conventional Loss-of-Resistance SyringeStandard saline loss-of-resistance technique using a conventional epidural syringe. The clinician applies intermittent or continuous pressure to the syringe plunger while advancing the epidural needle, interpreting a sudden reduction in resistance as entry into the epidural space. No investigational device is used in this arm. | Device | Conventional LOR Syringe |
Primary outcome
Measure number of attempts
Time frame: Intra-procedure
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
Measure false loss-of-resistance
Time frame: Intra-procedure
Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care
3 secondary outcomes
Measure device related and procedure-related adverse events
Time frame: Procedure day through approximately 1 week post-procedure
Change in pain intensity score on the 11-Point Numeric Rating Scale (NRS)
Time frame: Baseline before the procedure on Day 0 and approximately 3 hours, 24 hours, 48 hours, 72 hours, and 7 days after the procedure.
Clinician Usability Score on a 5-Point Likert Agreement Scale
Time frame: Immediately after completion of the index epidural procedure on Day 0, before participant discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Maja Green, PhD, MBA study director
Solaris Research Institute Inc
Krishnan Chakravarthy, MD, PhD principal investigator
Solaris Research Institute Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiFaith™ Syringe and Conventional Loss-of-Resistance Syringe in people with Chronic Pain, run by Flat Medical Co., Ltd at 2 sites in United States.
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 7 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: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maja Green, PhD, MBA (858-910-1778, mgreen@solarisresearchinstitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure number of attempts (time frame: Intra-procedure). 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 17 Jun 2026.