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NCT02884960
Safety and Efficacy of Embozene® Microspheres for Uterine Fibroid Embolization Compared to Embosphere® Microspheres for Symptomatic Relief From Uterine Fibroids
NA trial testing Uterine Fibroid Embolization in Uterine Fibroids in 118 participants. Status unknown.
1 October 2017
Quick facts
| Lead sponsor | Gary Siskin, MD |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 118 |
| Start date | 1 October 2016 |
| Primary completion | 1 October 2017 |
| Estimated completion | 1 October 2018 |
Drugs / interventions tested
- Uterine Fibroid Embolization
Conditions studied
- Uterine Fibroids — all drugs for Uterine Fibroids →
Sponsor
Gary Siskin, MD
Who can join
Adults 30 to 50, female only, with Uterine Fibroids. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Fibroid Infarction Rate
Time frame: 3 Months
The primary effectiveness endpoint for this study is the proportion of patients with a global rate of infarction for all fibroids present within the uterus that is \>90% as seen on contrast-enhanced MRI.
Sponsor's own description
The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Updates on Uterine Artery Embolization.
Kohi MP, Spies JB. · · 2018 · cited 38× · PMID 29628616 · DOI 10.1055/s-0038-1636521
Verify or expand the search:
- PubMed search for NCT02884960
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Uterine Fibroids
Currently open trials in the same condition.
- NCT07378098 — to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia · Phase 3 · recruiting
- NCT07486622 — Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical St · active not recruiting
- NCT06671548 — Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids · Phase 3 · recruiting
- NCT05448365 — Vitamin D, Epigallocatechin Gallate, D-chiro-inositol and Vitamin B6 in Uterine Fibroid · NA · recruiting
- NCT04126824 — Effect of Addition of Steroids on Duration of Analgesia · EARLY_PHASE1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02884960 (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 Gary Siskin, MD
- Last refreshed: 30 August 2016
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/NCT02884960.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing