NCT07654907
Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain Management
Not Yet Recruiting
NAAges 18+InterventionalFlat Medical Co., LtdInvestigator-initiated
~100 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:EpiFaith™ SyringeConventional Loss-of-Resistance Syringe
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure number of attempts
Measured over Intra-procedure
+1 more outcome measured
Conditions
Where it's being run
2 sites across 1 statesCalifornia2
Study leadership
- Maja Green, PhD, MBA · STUDY_DIRECTOR · Solaris Research Institute Inc
- Krishnan Chakravarthy, MD, PhD · PRINCIPAL_INVESTIGATOR · Solaris Research Institute Inc
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Exclusion
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.
What this trial measures
- Measure number of attemptsIntra-procedure
Measure: Number of puncture/needle placement attempts required to achieve successful epidural space access
- Measure false loss-of-resistanceIntra-procedure
Measure: False-positive loss-of-resistance (false LOR) rate, confirmed via epidurography/fluoroscopic contrast pattern when performed per routine care