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Cryoablation Versus Lumpectomy in Early-Stage Breast Cancer

NCT07483996 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 938

Last updated 2026-03-19

No results posted yet for this study

Summary

The goal of this randomised controlled trial is to compare ipsilateral breast cancer recurrence rates in patients with early-stage breast cancer between patients treated with breast conserving surgery and patient treated with percutaneous cryo-ablation.

Conditions

Interventions

PROCEDURE

Percutaneous cryoablation

In this trial, the IceCure Prosense Cryoablation System will be used to execute the percutaneous cryoablation procedure.

PROCEDURE

Breast-conserving surgery

Breast-conserving surgery

Sponsors & Collaborators

  • Franciscus Gasthuis & Vlietland (Hospital)

    lead OTHER

Principal Investigators

  • T.M.A.L. GE Klem, MD, PhD · Franciscus Gasthuis & Vlietland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2035-12-31
Completion
2038-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07483996 on ClinicalTrials.gov