BrightPoint Reflectometer Device Study

Epidural Placement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616299
• Other study ID #: STUDY20220677
• Status: Completed
• Phase: N/A
• Start date: April 28, 2023
• Est. completion date: June 23, 2023

Study information

• Verified date: August 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Placement

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Lumoptik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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