Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Novian Health Inc.
Study ID
NCT03463954
Status
Recruiting
Apply to this trial

Conditions

  • Malignant Neoplasm of Breast

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Novilase Laser ablation — DEVICE
    Image-guided, percutaneous laser ablation of breast tumors

Study Details

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.

Key Dates

Start date
Aug 9, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
122 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Percentage of target tumors completely ablated in one procedure [ Time Frame: 4-6 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UC San Diego HealthLa JollaCalifornia92037
Haydee Ojeda-Fournier, MD (PRINCIPAL_INVESTIGATOR)
Eisenhower HealthRancho MirageCalifornia92270
Azadeh Elmi, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06511
Kristen DeFrancesco
[email protected]
203-785-3852
John Lewin, MD (PRINCIPAL_INVESTIGATOR)
Liane Philpotts, MD (SUB_INVESTIGATOR)
Liva Andrejeva-Wright, MD (SUB_INVESTIGATOR)
Walter Reed National Military Medical CenterBethesdaMaryland20889-
Summit HealthFlorham ParkNew Jersey07932
Michelle McKenzie, RN
[email protected]
973-436-1755
Winnie Polen, DO (PRINCIPAL_INVESTIGATOR)
Buffalo General Medical CenterBuffaloNew York14203
Gabriel Rubio
[email protected]
Stuti Tambar, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAUC San Diego Health· La Jolla, CAEisenhower Health· Rancho Mirage, CAYale University· New Haven, CTWalter Reed National Military Medical Center· Bethesda, MDSummit Health· Florham Park, NJ

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