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The High Intensity Focused Ultrasound Evaluation and Assessment of Treatment (HEAT) Registry is a globally accessible, web-based platform for storing clinical data on patients treated with Sonablate HIFU.  It provides a unique aggregation of data that is organized for the purpose of advancing the collective knowledge about the clinical impact of HIFU on positive patient outcomes. This platform will allow researchers 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 comprehensive clinical information around the HIFU procedure.

 

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Data Collection

The HEAT registry provides intuitive means for users to enter, analyze, and audit their own personal databases as well as to collaborate internationally with colleagues on cross practice experience. Including both these personal data sets and globally “de-identified” patient data sets, participants will have a rich database of information.

 

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. Currently, The HEAT Registry has already enrolled more than 1,500 international patients.

The 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 (High Intensity Focused Ultrasound) physicians to input and track patient outcomes data.

HEAT REGISTRY DATA POINTS

HIFU Evaluation & Assessment of Treatment

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 salvage
  • 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)

Interested in speaking to someone about SonaCare Medical’s affiliation with The HEAT Registry? Please contact us at info@SonaCareMedical.com for more information.

HIFU company

Contact

10130 Perimeter Pkwy, Suite 250
      Charlotte, NC 28216

(888) 874-4384

info@SonaCareMedical.com

Mon - Fri: 9:00 - 5:00

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