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BrightPoint Reflectometer Device Study

NCT05616299 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-08-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Lumoptik, Inc.

    collaborator UNKNOWN

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Lora Levin, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2023-06-23
Completion
2023-06-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05616299 on ClinicalTrials.gov