HEAT Registry: Evaluating Sonablate® Clinical Data
High-Intensity Focused Ultrasound Evaluation and Assessment of Treatment Registry
This is a globally accessible, web-based platform used for storing clinical data on patients treated with Sonablate HIFU treatments. It provides a unique aggregation of data that is organized for the purpose of advancing the collective knowledge about the clinical impact of HIFU for prostate disease control on positive patient outcomes.
The aim of this platform is to rapidly accelerate the aggregate HIFU knowledge base, accumulate data from around the world on a single platform, and expedite the ability to assess outcomes.
The HEAT Registry will not only continue to build the clinical case for HIFU technology around the globe, but it will also provide patients with comprehensive clinical information about the HIFU procedure.
Data Collection
Solely overseen by academic professionals, the registry provides a reliable source of longitudinal data about the efficacy of HIFU and its developing importance in the realm of minimally invasive ablative prostate care and prostate disease treatment. Currently, The HEAT Registry has already enrolled more than 2,000 patients in the United States with thousands more internationally.
- Intuitive means for its users to enter, analyze, and audit their databases.
- The ability to collaborate with international colleagues on cross- practice experiences.
Database
Automated and easy to use, this electronic database is built on a robust web-based platform, the REDCap software system. REDCap was developed in the U.S. as a joint effort on the parts of Vanderbilt University, The National Center for Research Resources, and the National Institutes of Health, and is designed to comply with HIPAA regulations. This provides a secure location for all HIFU physicians to input and track patient outcomes data.
Heat Registry Data Points
Pre-Surgery Baseline
- Year of birth
- Name of surgeon
- PSA Value + PSA date
- Prostate Volume
- TNM Stage
- Date of biopsy
- Biopsy modality (transperineal, transrectal, etc.)
- Biopsy strategy (template, targeted)
- Gleason
- Number of positive cores
- Number of total cores
- Maximum Cancer Core Length
- Maximum Involvement
- Invasion seen (Y/N)
- Baseline Questionnaire Data
- Treatment Primary or Salvage
- Salvage staging data, if salvageable
- Radiotherapy dose/fractions, if primary treatment was radiotherapy
- Treatment date
- Treatment extent
- Pre-op hormone usage
- Treatment Complications
Post-Surgery Follow-Up
- PSA Value + PSA Date
- MRI Outcome + MRI Date
- Positive, negative, equivocal
- Biopsy Outcome + Biopsy Date
- Gleason
- Number of positive cores
- Number of total cores
- Maximum Cancer Core Length
- Modality
- Strategy
- Recurrence in-field or out of field
- Follow-up Questionnaire Data
- Retreatment Data
- Date of retreatment
- Type of retreatment
- Stage prior to retreatment
- Hormone Treatment
- Date hormone treatment prescribed
- Patient Death
- Date of Death
- Cause of Death Prostate Cancer Related (Y/N)