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NCT Number: NCT05616299

BrightPoint Reflectometer Device Study

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.

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Key information

Conditions

Epidural Placement

Age range

18 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient undergoing an epidural procedure

Exclusion criteria

  • Previous lumbar spine surgery
  • Any known spinal abnormality that would interferre with successfully advancing a needle into the epidural space
  • Any subject that requires an epidural needle longer than 4.0 inches
  • Any procedure requiring use of CSE needles
  • Any contraindication to neuraxial anesthesia
  • No subjects in advanced active labor, e.g., 6-8 cm dilated
  • Tattoo at the site of epidural insertion

Treatment and study plan

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.

Primary outcomes

  1. Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.

    Time frame: Up to 90 minutes

    This is measured as a Yes or No response.

Secondary outcomes

  1. Number of times epidural accessed while using BrightPoint device as measured by clinical log

    Time frame: Up to 90 minutes

  2. Number of times epidural catheter was used during the procedure as measured by clinical log

    Time frame: Up to 20 minutes

  3. Number of adverse events as measured by clinician log

    Time frame: Up to 90 minutes

  4. 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

  5. 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

  6. 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

  7. Number of times clinician experienced LOR after entering the epidural space as measured by clinician log

    Time frame: Up to 90 minutes

  8. 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

  9. Number of times there were issues with catheterization as measured by clinician log

    Time frame: Up to 90 minutes

  10. Number of times there were issues achieving pain management as measured by clinician log

    Time frame: Up to 4 hours

  11. Number of times the device indicated the needle tip was entering the LF as measured by clinician log

    Time frame: Up to 20 minutes

  12. 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

  13. 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

  14. Number of times the LOR and BrightPoint device agreed as measured by clinician log

    Time frame: Up to 90 minutes

  15. Number of times coring was observed during procedure as measured by clinician log

    Time frame: Up to 90 minutes

  16. 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

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Lumoptik, Inc.

Registry information

Official study title

Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2022
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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