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Pelvic Pain Treated With MR-guided Cryoanalgesia

NCT04046406 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-04-18

No results posted yet for this study

Summary

Pelvic pain syndromes have a high prevalence of up to 8% in the general population and up to 50% following pelvic trauma and pelvic surgery. While medical management is the initial therapeutic step, it is often ineffective with surgical decompression and resection of the putative nerves being the ultima ratio. Cryoablation can induce long-lasting nerve conduction blocks with resultant pain relief for several months. The objective of this study is to evaluate the effectiveness of magnetic resonance (MR) neurography-guided cryoanalgesia for the treatment of pelvic and associated pain syndromes.

Conditions

  • Pelvic Pain Syndrome
  • Groin Pain
  • Meralgia Paresthetica
  • Low Back Pain
  • Perineal Neuralgia

Interventions

DEVICE

MR neurography-guided cryoanalgesia

Treatment will be performed using a FDA-approved Galil Medical cryoablation system and FDA-approved Galil Medical cryoablation needles.

Sponsors & Collaborators

Principal Investigators

  • Jan Fritz, M.D · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-13
Primary Completion
2023-01-01
Completion
2023-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04046406 on ClinicalTrials.gov