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Cryoablation

MR neurography-guided cryoanalgesia for Pelvic Pain Syndrome

N/A
Waitlist Available
Led By Jan Fritz, M.D
Research Sponsored by Johns Hopkins 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 baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
Awards & highlights

Study Summary

This trial evaluates the effectiveness of cryoanalgesia, a treatment for pelvic pain that uses freezing temperatures to block nerves, guided by magnetic resonance neurography.

Eligible Conditions
  • Pelvic Pain Syndrome
  • Inguinal Pain
  • Meralgia Paresthetica
  • Perineal Neuralgia
  • Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in self-reported average pain score
Secondary outcome measures
Change in Self-Assessment of Treatment as assessed by a 5-item questionnaire
Change in analgesic medication use
Change in pain intensity as assessed by the Brief Pain Inventory (BPI)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pelvic pain syndromesExperimental Treatment1 Intervention
Patients with pelvic pain syndromes who will undergo MR neurography-guided cryoanalgesia

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,653 Total Patients Enrolled
BTG International Inc.OTHER
42 Previous Clinical Trials
3,086 Total Patients Enrolled
Jan Fritz, M.DPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

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

Are there any current opportunities to participate in the trial?

"This trial, which was initially advertised on the 13th of November 2019 and more recently updated on the 8th of December 2021, is actively seeking enrolment."

Answered by AI

Are individuals of advanced age eligible for inclusion in this experiment?

"This trial has set 18 years of age as the lower bound for enrollment, with an upper limit of 100."

Answered by AI

How many participants have signed up for this research endeavor?

"Affirmative, the information available on clinicaltrials.gov attests to this medical trial's active recruitment process. The initial post date was November 13th 2019 and the most recent update occurred on December 8th 2021. 50 participants are needed from 1 site for successful completion of the study."

Answered by AI

Does the criteria for this investigation encompass my individual circumstances?

"This trial is endeavouring to recruit 50 persons between 18 and 100 who are struggling with chronic lower back pain, despite having tried conservative treatments such as oral medication, physical therapy, or nerve block. The worst reported pain must be 4 or above on a 0-10 scale without the use of analgesics. To ensure selectivity of the nerve block treatment before cryoablation can occur within 3 months, MR images will demonstrate that only the targeted nerve has been injected with local anesthetic and there is no spread to other nerves in proximity. An adequate response for entry into this study necessitates at least a 50% reduction in pain after rest"

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
~0 spots leftby Apr 2025