Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Sarasota Memorial Health Care System
Study ID
NCT06868459
Status
Enrolling By Invitation

Conditions

  • Hyperthyroidism
  • Hyperthyroidism; Goiter
  • Multinodular Goiter
  • Thyroid Disease
  • Thyroid Nodules
  • Toxic Multinodular Goiter

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Data Collection — OTHER
    Subjects with planned PED-TAE delivered via TriNav will receive their treatment following routine standard of care procedures. Post-procedural data obtained by a patient chart review will be collected in a study database. No additional study-specific interventions or visits outside of the routine clinical treatment will be performed.

Study Details

Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.

Key Dates

Start date
Apr 1, 2025
Status verified
Mar 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Patients who have undergone PED-TAE using the TriNav Infusion System at participating study sites.
    Subjects with planned PED-TAE delivered via TriNav will receive their treatment following routine standard of care procedures. Post-procedural data obtained by a patient chart review will be collected in a study database. No additional study-specific interventions or visits outside of the routine clinical treatment will be performed.

Primary Outcome Measure

ThyPro-39 questionnaire [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarasota Memorial Health Care SystemSarasotaFlorida34239-

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Sarasota Memorial Health Care System· Sarasota, FL

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