An interventional study of BrightPoint in Epidural Placement, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-08.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Device feasibility
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.
University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive an epidural using the BrightPoint device concurrent with usual LOR technique using the same epidural needle, sterile saline, syringe, etc.
Device: BrightPoint
Subjects will have an epidural placed in usual manner with LOR technique using the same epidural needle, sterile saline, syringe etc. but without use of the BrightPoint device.
Data from the BrightPoint device during epidural placement will be collected in real time on a tablet with pre-programmed software including tissue color and light reflectance with time stamps of when epidural space is entered as voiced by clinician per LOR.
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.
This is measured as a Yes or No response.
Time frame: Up to 90 minutes
Number of times epidural accessed while using BrightPoint device as measured by clinical log
Time frame: Up to 90 minutes
Number of times epidural catheter was used during the procedure as measured by clinical log
Time frame: Up to 20 minutes
Number of adverse events as measured by clinician log
Time frame: Up to 90 minutes
Number of times the BrightPoint device provided real-time secondary confirmation of Loss of Residence (LOR) as measured by clinician log
Time frame: Up to 90 minutes
Number of times the BrightPoint device provided beneficial qualitative/quantitative clinical information to help complete the epidural as measured by clinician log.
Time frame: Up to 90 minutes
Number of times clinician experienced the haptic feel of entering the ligamentum flavum (LF) as measured by clinician log
Time frame: Up to 90 minutes
Number of times clinician experienced LOR after entering the epidural space as measured by clinician log
Time frame: Up to 90 minutes
Number of times clinician experienced the haptic sensation of the needle contacting any tissue that was not expected as measured by clinician log
Time frame: Up to 90 minutes
Number of times there were issues with catheterization as measured by clinician log
Time frame: Up to 90 minutes
Number of times there were issues achieving pain management as measured by clinician log
Time frame: Up to 4 hours
Number of times the device indicated the needle tip was entering the LF as measured by clinician log
Time frame: Up to 20 minutes
Number of times the device showed a significant change of color from the light in LF to the dark in ES as measured by clinician log
Time frame: Up to 90 minutes
Number of times the device showed a significant change of reflectance from high in LF to low in ES as measured by clinician log
Time frame: Up to 90 minutes
Number of times the LOR and BrightPoint device agreed as measured by clinician log
Time frame: Up to 90 minutes
Number of times coring was observed during procedure as measured by clinician log
Time frame: Up to 90 minutes
Number of times the BrightPoint interfered with the ability to perform the epidural placement in the usual manner with LOR and haptic feedback as measured by clinician log
Time frame: Up to 90 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center