Clinical trial · Interventional
Hysteroscopic Cryomyolysis for the Treatment of Submucosal Leiomyomata
Feasibility Study of Hysteroscopic Cryoablation Treatment of Symptomatic Uterine Fibroids in Women Who do Not Desire Further Pregnancies
NCT00731341CI-TRIAL-00052751completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the current study is to evaluate the technical success, safety and procedure feasibility of hysteroscopic cryoablation treatment of symptomatic uterine fibroids in women who do not desire further pregnancies using Galil Medical's 17-gauge 400mm Argon-based cryoablation needles
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Menorrhagia | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation for the treatment of uterine fibroids | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hysteroscopic cryoablation
- description
- Women undergoing hysteroscopic ultrasound guided cryoablation for the treatment of uterine fibroids.
- interventionNames
- Procedure: Cryoablation for the treatment of uterine fibroids
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- up to 4 weeks post procedure.
- description
- Safety of the procedure will be assessed by incidence and severity of intra and post procedure related adverse events (AEs)
Secondary outcomes (5)
- measure
- Hysteroscopic Cryoablation Related Pain Will be Measured by Self Reported Pain Severity Visual Analogue Scale (VAS) Completed by the Patient
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Primary complaint is excessive bleeding * Subject is able to understand and give informed consent for participation in the study * Pre-menopausal woman between the ages of 30 and 50 (inclusive) * Has completed childbearing and not contemplating future fertility * Has symptomatic uterine fibroids * Fibroids type, size, location and number * 1 submucosal fibroid * Type I and Type II fibroids * 2 to 4cm * Using contraception to prevent pregnancy Exclusion Criteria: * Any evidence of known or suspected infection or pre-malignancy/malignancy * Desire for future child bearing * Fibroids * Size \> 4cm * 2 or more submucosal fibroids * Fibroid distance from the serosa is less than 1 cm
References
Publications (0)
Data not yet available
No reference posted for this study.