Trials / Enrolling By Invitation
Enrolling By InvitationNCT06868459
Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Sarasota Memorial Health Care System · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Hyperthyroidism; Goiter
- Multinodular Goiter
- Thyroid Nodules
- Thyroid Disease
- Hyperthyroidism
- Toxic Multinodular Goiter
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Data Collection | 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. |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2027-04-01
- Completion
- 2028-04-01
- First posted
- 2025-03-11
- Last updated
- 2025-09-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06868459. Inclusion in this directory is not an endorsement.