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Not Yet Recruiting
NCT05616299
BrightPoint Reflectometer Device Study
Conditions: Epidural Placement
Sex: Female
Ages: 18 Years – 79 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 204
Sponsor: Lora Levin, MD
Location: United States
Summary
Participants are being asked to participate in this study because they are having an epidural placed for labor.
This human clinical trial has been designed to evaluate the use of the BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss of Residence (LOR) for lumbar epidural placement by an experienced clinician.
For this study, participants will be randomized to receive an epidural by an experienced clinician either with or without the use of the BrightPoint device.
Epidurals performed as a part of this study will be done in a manner similar to how epidurals are currently performed in the hospital.
The epidural space will be entered using usual loss of resistance technique for all patients.
If the BrightPoint device is used, it will be as secondary verification of entry into the epidural space.
Eligibility Criteria
Inclusion Criteria:Any patient undergoing an epidural procedureExclusion Criteria:Previous lumbar spine surgeryAny known spinal abnormality that would interferre with successfully advancing a needle into the epidural spaceAny subject that requires an epidural needle longer than 4.0 inchesAny procedure requiring use of CSE needlesAny contraindication to neuraxial anesthesiaNo subjects in advanced active labor, e.g., 6-8 cm dilatedTattoo at the site of epidural insertion
Source: ClinicalTrials.gov (NCT05616299). StuddyBuddy aggregates publicly available trial information.