New syringe aims to take the guesswork out of epidural pain relief
NCT ID NCT07654907
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new device called the EpiFaith™ Syringe, which gives a clear visual signal when a doctor reaches the right spot for an epidural pain injection. Currently, doctors rely on feel alone, which can lead to multiple needle sticks or mistakes. The study will compare the new syringe to the standard method in 100 adults having epidural procedures for chronic pain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- EpiFaith™ Syringe (a device with a spring-loaded piston that shows a visual signal when the epidural space is reached)
- What this could lead to
- If it works, this device could make epidural pain procedures more accurate and less reliant on a doctor's feel, potentially reducing needle sticks and false signals.
- What could go wrong
- This is a small, early-stage study with only 100 people, and it is not randomized. The device may not work better than the standard method, and results may not apply to all patients or settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Innovative Pain Treatment Solutions
San Diego, California, 92111, United States
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Innovative Pain Treatment Solutions
Temecula, California, 92590, United States
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