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VerTouch Device for Pain and Pregnancy
N/A
Waitlist Available
Led By Mahesh Vaidyanathan, MD
Research Sponsored by Northwestern University
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 end of procedure
Awards & highlights
Study Summary
This trial will compare the VerTouch device to palpation and ultrasound (US) techniques used to identify the best location for a needle during a spinal tap.
Who is the study for?
This trial is for adults over 18 who need a neuraxial procedure, like an epidural or spinal anesthesia. It's not for those with plastic allergies, non-English speakers, or anyone unable to give written consent.Check my eligibility
What is being tested?
The study compares the VerTouch device against traditional palpation and ultrasound techniques in finding the best spot for neuraxial procedures during pain management in pregnancy.See study design
What are the potential side effects?
While this trial focuses on procedural accuracy rather than medication, potential side effects may include discomfort at the site of application from either VerTouch or standard methods.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of insertions of the needle
Number of redirections of the needle
Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Group 4: VerTouch for lumbar puncture procedureExperimental Treatment1 Intervention
VerTouch utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture.
Group II: Group 1: VerTouch for labor epidural or spinal anesthesia procedureExperimental Treatment1 Intervention
VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group III: Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedureActive Control1 Intervention
Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Group IV: Group 5: Ultrasound (US) for lumbar puncture procedureActive Control1 Intervention
Ultrasound (US) utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture.
Group V: Group 6: Control group, palpation for lumbar puncture procedureActive Control1 Intervention
Control group, palpation utilized for identification of site for lumbar puncture procedure in patients who require a therapeutic lumbar puncture.
Group VI: Group 3: Control group, palpation for labor epidural or spinal anesthesia procedureActive Control1 Intervention
Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure in women requesting labor analgesia.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure
2021
N/A
~90
Group #4: VerTouch utilized for identification of site for lumbar puncture procedure
2021
N/A
~90
Find a Location
Who is running the clinical trial?
IntuitapUNKNOWN
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,142 Total Patients Enrolled
46 Trials studying Pain
3,671 Patients Enrolled for Pain
Mahesh Vaidyanathan, MDPrincipal InvestigatorNorthwestern University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to plastic.You are having a procedure that involves the spine and its surrounding nerves.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: VerTouch for labor epidural or spinal anesthesia procedure
- Group 2: Group 2: Ultrasound (US) for labor epidural or spinal anesthesia procedure
- Group 3: Group 4: VerTouch for lumbar puncture procedure
- Group 4: Group 5: Ultrasound (US) for lumbar puncture procedure
- Group 5: Group 6: Control group, palpation for lumbar puncture procedure
- Group 6: Group 3: Control group, palpation for labor epidural or spinal anesthesia procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an enrollment process for this clinical trial?
"Per records on clinicaltrials.gov, this research is currently in the process of recruitment for participants. The original posting date was January 1st 2021 and it has been updated as recently as September 3rd 2021."
Answered by AI
How many individuals are enrolled in this clinical investigation?
"Affirmative. According to the information shared on clinicaltrials.gov, this study is currently recruiting patients and was initially posted on January 1st 2021 with its most recent update occurring on September 3rd 2021. The trial seeks 120 participants at a single medical facility."
Answered by AI
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