Recruiting

Novilase®

Sponsor:

Novian Health Inc.

Code:

NCT03463954

Conditions

Malignant Neoplasm of Breast

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Novilase Laser ablation

Study Details

Brief summary:

Prior to this confirmatory pivotal study, the multicenter Br-002 feasibility study was completed. 98% of tumors less than or equal to 15mm were completely ablated in one procedure.This study will evaluate Novilase for the focal destruction of malignant tumors of the breast that are less than or equal to 15 mm against a performance goal for the standard of care, lumpectomy. The ASBrS' goal of less than 20% retreatment by 2020 was selected as a representative performance goal, i.e., 80.0%, and is consistent with published effectiveness rates for lumpectomy.

Conditions

Malignant Neoplasm of Breast

Study ID

NCT03463954

Start date

Aug 9, 2023

Status verified date

Oct, 2025

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females, aged 18 years and older
  • Able to give written informed consent herself
  • Definitive pathologic diagnosis by needle core biopsy
  • Unifocal malignant tumor (T1a-c, N0-1, M0) that does not exceed 15 mm in longest dimension and measures at least 5 mm away from the skin and chest wall, or can be moved at least 5 mm away from the skin and chest wall by injection of saline or local anesthetic
  • No more than 10 mm of calcifications confined to the tumor on imaging
  • Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images)
  • Tumor is well visualized on MRI
  • Subject with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
  • Tumor with less than 25% intraductal component, as determined by core biopsy
  • No clinically significant co-morbidities (e.g., chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy
  • Subject weight limited to ≤300 lbs. or ≤136 kg
  • Subject agrees to comply with standard of care radiation or adjuvant therapy as prescribed by physician

Exclusion Criteria:

  • Subject younger than 18 years of age
  • Pregnant or breast-feeding
  • Tumor poorly visualized by ultrasound or x-ray mammography imaging
  • Contraindications to administration of gadolinium-based contrast agent, including: prior allergic reaction to a gadolinium-based contrast agent, moderate to end-stage kidney disease, and/or acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq. meters)
  • Contraindications to MRI according to site guidelines (e.g., cardiac pacemaker, metallic implants)
  • History of severe asthma
  • Tumor measuring greater than 15 mm in longest dimension
  • Microcalcifications that extend beyond target tumor such that overall longest dimension of target tumor and calcifications is longer than 15 mm.
  • Advanced stage breast cancer
  • Tumors that are lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phyllodes tumor, or Paget's disease
  • Tumor with only DCIS with microinvasion
  • Extensive intraductal component in lesion (i.e., >25%) as determined by core biopsy
  • Subject who is known to be BRCA positive
  • Tumor that is ER/PR/HER2 negative (TNBC)
  • Inability to lie in prone or supine position for one hour
  • Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial
  • Subject without a definitive HER2 test according to ASCO/CAP guidelines

Study Design

Enrollment

122 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Novilase Laser Ablation and excision

Eligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care.

Interventions

Novilase Laser ablation

Image-guided, percutaneous laser ablation of breast tumors

Primary outcome measure

  • Percentage of target tumors completely ablated in one procedure [ Time Frame: 4-6 weeks ]
  • Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery [ Time Frame: 4-6 weeks ]

Central Contacts and Locations

Central contacts

Eugene Bajorinas

3122667200ebajorinas@novianhealth.com

Chip Appelbaum

3122667200info@novianhealth.com

Locations

UC San Diego Health

Recruiting

La Jolla, California, United States, 92037

Principal Investigator:

Haydee Ojeda-Fournier, MD

Eisenhower Health

Recruiting

Rancho Mirage, California, United States, 92270

Principal Investigator:

Azadeh Elmi, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Kristen DeFrancesco

203-785-3852kristin.defrancesco@yale.edu

Principal Investigator:

John Lewin, MD

Buffalo General Medical Center

Recruiting

Buffalo, New York, United States, 14203

Contacts

Gabriel Rubio

Grubio@gppconline.com

Principal Investigator:

Stuti Tambar, MD

More Information

Sponsor

Novian Health Inc.

Last update posted

Feb 19, 2026

Last verified

Oct, 2025

Keywords

  • less than or equal to 15 mm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novian Health Inc. on 2026-02-19.