Pain Severity and Pain Interference Outcomes following Percutaneous MRI-Guided Laser Ablation and Cryoablation of Painful Peripheral, Soft Tissue Vascular Anomali
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-004662
Sponsor Protocol Number: 16-004662
About this study
The purpose of this study is to determine if MRI-guided laser ablation and cryoablation result in significant improvements in both pain severity and pain interference measures at intermediate-term follow-up in patients with painful, soft-tissue vascular anomalies. The study will also test the hypothesis that immediate loss of intrinsic vascular anomaly T2 signal is an imaging biomarker to predict decreased pain and VA volume following MRI-guided laser ablation and cryoablation in patients with painful, soft-tissue vascular anomalies.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients with an imaging diagnosis of a vascular anomaly and vascular anomaly associated pain (Pain score of 4 or higher on a scale of 0–10 for the question, “Please rate your pain by circling the one number that best describes your worst pain over the past 24 hours”) referred for clinically indicated MRI-guided percutaneous laser ablation or cryoablation using FDA approved ablation devices who consent to study participation.
Exclusion Criteria:
- Adult patients with an imaging diagnosis of a vascular anomaly and vascular anomaly associated pain (Pain score of 3 or less on a scale of 0–10 for the question, “Please rate your pain by circling the one number that best describes your worst pain over the past 24 hours”) referred for clinically indicated MRI-guided percutaneous laser ablation or cryoablation using FDA approved ablation devices who consent to study participation.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available