Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT03463954 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE Novilase Laser ablation

Study Locations (13)

Other

  • St. Elisabeth-Krankenhaus Köln-Hohenlind — Cologne
  • Ichilov | Tel Aviv Sourasky Medical Center — Tel Aviv
  • Breast Centre Zurich — Zurich
  • University Hospital Zurich — Zurich
  • Charing Cross Hospital, Imperial College Healthcare NHS Trust — London
  • Churchill Hospital, Oxford University Hospitals NHS Trust — Oxford

California

  • City of Hope — Duarte
  • UC San Diego Health — La Jolla
  • Eisenhower Health — Rancho Mirage

Connecticut

  • Yale University — New Haven

Maryland

  • Walter Reed National Military Medical Center — Bethesda

New Jersey

  • Summit Health — Florham Park

New York

  • Buffalo General Medical Center — Buffalo

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2023-08-09
Est. Completion 2027-03-30
Phase NA

Sponsor

Novian Health

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03463954

The ClinicalTrials.gov registry entry for NCT03463954 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novian Health, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Malignant Neoplasm of Breast appearing as the primary indexed condition, and to 1 intervention — of which Novilase Laser ablation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03463954 reports 13 study locations spanning 6 distinct geographic areas — top geographies include Other, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03463954 about?

NCT03463954 is a clinical study titled "Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors". 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 equa...

What is the current status of trial NCT03463954?

This trial is currently recruiting. It is a NA study. The enrollment target is 122 participants. The study started on 2023-08-09. Estimated completion is 2027-03-30.

What conditions does trial NCT03463954 study?

This clinical trial studies the following conditions: Malignant Neoplasm of Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03463954?

The interventions under investigation include: Novilase Laser ablation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03463954?

This trial is sponsored by Novian Health, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03463954 being conducted?

This trial has 13 study locations across California, Connecticut, Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial