JHU ICTR
Johns Hopkins Clinical Research Study

Pelvic Pain treated with MR-guided Cryonanalgesia
ClinicalTrials.gov

IRB Number: IRB00222178
Principal Investigator: Fritz, Jan

Study Description:

This is a prospective, single-center and single-arm study. Patients with chronic pelvic pain syndrome due to an identifiable neuropathy who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation treatment will be offered enrollment into the study. Only patients with clinical indication and referral for MR-guided cryoanalgesia are eligible to participate. Patients will not receive any additional ionizing nor non-ionizing radiation as part of their participation in this observational study and serving as their own control. They will receive their routine standard of care, which will not be affected by this study.  Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. As part of our study, we will administer an in-person pre-procedure questionnaire to patients of therapeutic image-guided procedures, which will collect information regarding any prior image-guided interventional procedures they have undergone as well as information about their feelings of being informed and comfortable with the procedure they will undergo. We will then administer an immediate post-procedure in-person questionnaire in the post-procedure recovery area, which will gather information about the patient's experience in the scanner and during the procedure if their experience matched their expectations, their symptoms during and immediately after the procedure, and so on. Treatment will be performed using our Galil Medical cryoablation system and Galil Medical cryoablation needles that are installed on the interventional floor on Bloomberg 4. This system is FDA-approved. Subjects will have a cryoablation procedure and will be followed by in-office visits, phone-based interviews and email surveys for up to 24 months for symptoms including pain, quality of life and analgesic usage. The in-office visits, phone-based interviews, and email surveys will be completely voluntary without monetary compensation. No medical advice or recommendation, or patient-physician communication will be performed during the phone interview.



Eligibility Criteria:

Inclusion criteria:

  1. 18 years of age or older

Chronic pelvic pain for at least 3 months and no adequate pain relief defined as persistent worst pain 4 or above 4 or above on an 11-point visual analogue scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite conservative treatments, including but not limited to oral pain medication including NSAIDs and narcotics, physical therapy, and nerve block.

  1. The ‘worst pain’ must be reported to be 4 or above on an 11-point visual analogue scale of 0     (no pain) to 10 (pain as bad as subject can imagine)
  2. Pain must be from a single lumbosacral nerves confirmed with selective nerve blocks providing adequate temporary pain. The selectivity of the nerve block will be confirmed on MR images documenting that the injected local anesthetic immerses the targeted nerve and that there is the absence of spread of local anesthetic to adjacent nerves to exclude confounding anesthesia. Adequate pain relief will be defined by pain relief of greater 50% after the nerve block and rest and with aggravating exercise.
  3. The target nerve is amenable to cryoablation with MRI guidance
  4. Cryoablation should be performed within 3 months of the nerve block
  5. No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
  6. Known coagulopathy or bleeding disorders are controlled

 

Exclusion criteria:

  1. Confounding pain syndromes or conditions.
  2. Previous nerve surgery
  3. Currently pregnant, nursing, or wishing to become pregnant during the study
  4. Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, a cerebrovascular event within 6 months prior to the screening visit
  5. Concurrent participation in other studies that could affect the primary endpoint


Recruitment Contact Name:Dr. Jan Fritz
Contact Phone:443-287-2917
Contact E-Mail: jfritz9@jhmi.edu


Location of Study Visits:

  • Johns Hopkins Hospital East Baltimore Campus

Study will provide compensation: No



Keywords:

  • Pelvic Pain
  • Magnetic Resonance Imaging, Interventional
  • Cryosurgery