NCT05616299

BrightPoint Reflectometer Device Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• Epidural Placement

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-28
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2022-11-15
• Last updated: 2023-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study