MR neurography-guided cryoanalgesia for Pelvic Pain Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pelvic Pain Syndrome+4 MoreMR neurography-guided cryoanalgesia - Device
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

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
  • Lower Back Pain
  • Perineal Neuralgia
  • Meralgia Paresthetica

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

Week 12
Change in self-reported average pain score
Month 18
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)
Change in pain interference as assessed by the BPI
Change in percentage pain relief

Trial Safety

Trial Design

1 Treatment Group

Pelvic pain syndromes
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: MR neurography-guided cryoanalgesia · No Placebo Group · N/A

Pelvic pain syndromes
Device
Experimental Group · 1 Intervention: MR neurography-guided cryoanalgesia · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1, 3, 6, 9, 12, and 18 months post cryoablation procedure

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,076 Previous Clinical Trials
31,020,143 Total Patients Enrolled
BTG International Inc.OTHER
41 Previous Clinical Trials
3,194 Total Patients Enrolled
Jan Fritz, M.DPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18 - 100 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
old People between the ages of 18 and 100 years old.
Chronic pelvic pain that doesn't improve with standard treatments like medication, physical therapy, and nerve blocks may be caused by a problem with the nervous system.
The person must report the pain to be at a 4 or higher on a scale of 0 to 10.
This means that the nerve can be frozen using MRI guidance.
The patient's pain must be due to a single lumbosacral nerve, as confirmed by selective nerve blocks that provide adequate temporary pain relief
with heparin People with known coagulopathy or bleeding disorders are treated with heparin in order to control their condition.
care No medical or psychiatric illness that would prevent giving consent or receiving treatment.
Cryoablation should be performed within 3 months of the nerve block.

Who else is applying?

What state do they live in?
Maryland100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%