BrightPoint Reflectometer Device Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2023-06-23

Brief Summary

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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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Detailed Description

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Conditions

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Epidural Placement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BrightPoint

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes