BrightPoint Reflectometer Device Study

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

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.

Study Overview

• Status: Completed
• Conditions: Epidural Placement
• Intervention / Treatment: Device: BrightPoint

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BrightPoint Epidural; 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; 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.
No Intervention: Normal Epidural; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.	This is measured as a Yes or No response.	Up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of times epidural accessed while using BrightPoint device as measured by clinical log	Up to 90 minutes
Number of times epidural catheter was used during the procedure as measured by clinical log	Up to 20 minutes
Number of adverse events as measured by clinician log	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	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.	Up to 90 minutes
Number of times clinician experienced the haptic feel of entering the ligamentum flavum (LF) as measured by clinician log	Up to 90 minutes
Number of times clinician experienced LOR after entering the epidural space as measured by clinician log	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	Up to 90 minutes
Number of times there were issues with catheterization as measured by clinician log	Up to 90 minutes
Number of times there were issues achieving pain management as measured by clinician log	Up to 4 hours
Number of times the device indicated the needle tip was entering the LF as measured by clinician log	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	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	Up to 90 minutes
Number of times the LOR and BrightPoint device agreed as measured by clinician log	Up to 90 minutes
Number of times coring was observed during procedure as measured by clinician log	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	Up to 90 minutes

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Lumoptik, Inc.
• Investigators: Principal Investigator: Lora Levin, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Actual): June 23, 2023
• Study Completion (Actual): June 23, 2023

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Epidural; Labor
• Other Study ID Numbers: STUDY20220677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No