NCT06537141

Brief Summary

To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Aug 2024Jul 2026

First Submitted

Initial submission to the registry

July 12, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

August 10, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2026

Expected
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

July 12, 2024

Last Update Submit

August 1, 2024

Conditions

Keywords

Embolization of thyroid arteries

Outcome Measures

Primary Outcomes (2)

  • To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

    Safety measured according to incidence of major and minor complications compared to thyroidectomy.

    Up to 12 months follow up after embolization

  • To investigate the efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

    in hyperfunctiong (toxic) disorders Efficacy measured according to thyroid profile levels in certain time interval post procedure, every 3 months time interval and rate of hyper functioning recurrence in comparison to thyroidectomy. In diffuse or nodular goiter we measure efficacy by percentage of size reduction post procedure in comparison to primary size just before procedure

    Up to 12 months follow up after embolization

Study Arms (2)

graves disease patients

ACTIVE COMPARATOR
Procedure: selective embolization of thyroid arteries (SETA)

multinodular goiter

ACTIVE COMPARATOR
Procedure: selective embolization of thyroid arteries (SETA)

Interventions

selective embolization of thyroid arteries

graves disease patientsmultinodular goiter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A- diffuse and Nodular goiter:
  • B-Toxic goiter:
  • C-Thyroid cancer:

You may not qualify if:

  • A. Significant bleeding diathesis. B. Contraindication for contrast media (renal impairment or allergy). C. Severe atherosclerotic disease prevent arterial catheterization. D. Refusal of signing a consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Graves DiseaseGoiter, Nodular

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

July 12, 2024

First Posted

August 5, 2024

Study Start

August 10, 2024

Primary Completion (Estimated)

July 9, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

August 5, 2024

Record last verified: 2024-08