RECRUITING

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to test the BrightPoint Epidural device as the first system to use multispectral reflectometry to find the epidural space in lumbar neuraxial procedures requiring epidural needle. The main questions it aims to answer are: 1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance? 2. Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals? Participants will undergo a neuraxial procedure in which the attending anesthesiologist will use the BrightPoint epidural device to form an opinion on its effectiveness in confirming epidural space access.

Official Title

Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device As Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement

Quick Facts

Study Start:2023-09-12
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06020508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
  2. * Age 18-99
  1. * Previous lumbar spine surgery
  2. * Any known spinal abnormality that would interfere with successfully advancing a needle into the epidural space
  3. * Any patient requiring epidural needle longer than 4 inches
  4. * Any contraindication to neuraxial anesthesia
  5. * Tattoo at the site of epidural insertion

Contacts and Locations

Study Contact

Justas Lauzadis, PhD
CONTACT
212-774-2946
lauzadisj@hss.edu
Pa Thor, PhD
CONTACT
646-797-8535
thorp@hss.edu

Principal Investigator

Michael Singleton, MD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Michael Singleton, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-12
Study Completion Date2025-04

Study Record Updates

Study Start Date2023-09-12
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • epidural
  • neuraxial

Additional Relevant MeSH Terms

  • Lumbar Spine Surgery