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BrightPoint Epidural for Epidural

N/A
Waitlist Available
Research Sponsored by Lora Levin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 minutes
Awards & highlights

Study Summary

This trial explores if using a device can help confirm epidural placement during childbirth. Participants will be randomized to receive epidural with or without the BrightPoint device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.
Secondary outcome measures
Number of adverse events as measured by clinician log
Number of times clinician experienced LOR after entering the epidural space as measured by clinician log
Structure of ligamentum flavum
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BrightPoint EpiduralExperimental Treatment1 Intervention
Subjects will receive an epidural using the BrightPoint device concurrent with usual LOR technique using the same epidural needle, sterile saline, syringe, etc.
Group II: Normal EpiduralActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BrightPoint
2023
N/A
~10

Find a Location

Who is running the clinical trial?

Lora Levin, MDLead Sponsor
University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,351 Total Patients Enrolled
Lumoptik, Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it permissible for me to join in this experiment?

"Criteria for participation in this research includes epidural placement and an age range of 18-79. A total of 204 individuals are being accepted."

Answered by AI

Is this research project currently accepting participants?

"According to clinicaltrials.gov, this trial has concluded its recruitment of candidates. It was first made available on December 1st 2022 and last updated November 15th 2022. Although the study is not actively seeking patients anymore, there are still other medical studies that have open enrollment currently underway."

Answered by AI

Is there an age ceiling for enrolment in this research program?

"The prerequisites for participating in this trial set the minimum age at 18, with an upper limit of 79 years old."

Answered by AI
~2 spots leftby Mar 2025