Who is sponsoring NCT03323905?

NCT03323905 is sponsored by Sunnybrook Health Sciences Centre.

What drugs are being tested in NCT03323905?

Interventions in NCT03323905: Symphony MRI guided High Intensity Focused Ultrasound (HIFU).

What condition does NCT03323905 study?

NCT03323905 studies Leiomyoma, Fibroid.

Is NCT03323905 still recruiting?

NCT03323905 is currently completed. Last updated 9 July 2024.

Last reviewed 2024-07-09 · How we verify

NCT03323905: HIFUSB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Completed NA Last updated 9 July 2024

What this trial tests

NA trial testing Symphony MRI guided High Intensity Focused Ultrasound (HIFU) in Leiomyoma in 50 participants. Completed in 3 March 2024.

Timeline

16 November 2017

Primary endpoint
1 December 2023

3 March 2024

Quick facts

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	16 November 2017
Primary completion	1 December 2023
Estimated completion	3 March 2024
Sites	1 location across Canada

Drugs / interventions tested

Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

Conditions studied

Leiomyoma — all drugs for Leiomyoma →
Fibroid — all drugs for Fibroid →

Sponsor

Sunnybrook Health Sciences Centre — full company profile →

Who can join

18 and older, female only, with Leiomyoma or Fibroid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

High-Intensity Focused Ultrasound: A Review of Mechanisms and Clinical Applications.
Bachu VS, Kedda J, Suk I, Green JJ, et al · · 2021 · cited 166× · PMID 34374945 · DOI 10.1007/s10439-021-02833-9
Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393
Transducer module apodization to reduce bone heating during focused ultrasound uterine fibroid ablation with phased arrays: A numerical study.
Goudarzi S, Jones RM, Lee YHW, Hynynen K. · · 2024 · cited 2× · PMID 39341358 · DOI 10.1002/mp.17427
Anti-focus driving signals to mitigate bone heating during focused ultrasound ablation of uterine fibroids with phased arrays.
Sadeghi-Goughari M, Jones RM, Hynynen K. · · 2026 · PMID 42173149 · DOI 10.1088/1361-6560/ae7248

Verify or expand the search:

Other recruiting trials for Leiomyoma

Currently open trials in the same condition.

NCT06143631 — Prescription of Letrozole for Uterine Myoma · Phase 4 · recruiting
NCT06135870 — Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study) · recruiting
NCT03400826 — Effects of Simvastatin on Uterine Leiomyoma Size · Phase 2 · recruiting

Other Sunnybrook Health Sciences Centre trials

Trials by the same sponsor.

NCT07478705 — Early Detection of Metastatic Recurrence Among Patients With Stage II or III Triple Negative Breast Cancer Using Liquid · NA · not yet recruiting
NCT07376018 — Ketogenic Diet and Neuromodulation in Treatment Resistant Depression · NA · not yet recruiting
NCT07350278 — Comparing Virtual Reality Simulation to High Fidelity Simulation as an Educational Modality for Electroconvulsive Therap · NA · not yet recruiting
NCT07191145 — Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT) · Phase 3 · not yet recruiting
NCT07308587 — Evaluation of Intercostal Neuralgia in Patients With Chest Tube Insertion After Traumatic Rib Fracture · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03323905 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sunnybrook Health Sciences Centre
Last refreshed: 9 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03323905.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing