NCT05616299

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

November 7, 2022

Last Update Submit

August 7, 2023

Conditions

Epidural Placement

Keywords

LaborEpidural

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (2)

BrightPoint Epidural

EXPERIMENTAL

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

Normal Epidural

NO INTERVENTION

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.

Interventions

BrightPointDEVICE

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.

BrightPoint Epidural

Eligibility Criteria

Age18 Years - 79 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient undergoing an epidural procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

  • Lora Levin, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 15, 2022

Study Start

April 28, 2023

Primary Completion

June 23, 2023

Study Completion

June 23, 2023

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)