Clinical trial · Interventional
Cryotherapy in Breast B3 Lesions
Pilot Study on the Feasibility of Cryotherapy as an Alternative Treatment for Phyllodes Tumors/Breast Fibroepithelial Lesions (FELs) Needing Surgery
NCT04571307CI-TRIAL-00053719unknownN/AClinicalTrials.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)
To determine the feasibility of cryotherapy for B3 fibroepithelial lesions
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Disease | — | UNRESOLVED | — |
| Phyllodes Breast Tumor | Breast Phyllodes Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- recurrence of the lesion
- timeFrame
- 2 years from procedure
- description
- assessed on ultrasound
- measure
- breast cosmetic outcome
- timeFrame
- at 1 year post procedure
- description
- patient self assessment of excellent (1), good (2), fair (3) poor (4). score of 1-4,1 being the best score
- measure
- pain score
- timeFrame
- immediate post procedure
- description
- using pain score scale of 0-10, a higher score indicates a worse outcome
- measure
- pain score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * lesion seen on ultrasound * core biopsy revealed FEL of B3 * lesion \</+3.5cm * keen for cryotherapy instead of surgery * has other breast lesions for followup Exclusion Criteria: * cancer patients * patients with bleeding diathesis * lesions causing visible breast deformity
References
Publications (0)
Data not yet available
No reference posted for this study.