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NCT03463954 · ClinicalTrials.gov registry record · NA

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

A NA study of Malignant Neoplasm of Breast, sponsored by Novian Health.

Recruiting
Registry status
NA
Development phase
122
Enrollment target
13
Study locations

NCT03463954 is a NA study of Malignant Neoplasm of Breast that is actively recruiting participants, run by Novian Health. The registered enrollment target is 122 participants, above the 49-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (149% higher). The trial reports 13 study locations across 6 states.

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The verdict

NCT03463954, a NA study of Malignant Neoplasm of Breast, is actively recruiting participants, sponsored by Novian Health.

RECRUITING
Registry status
NA
Development phase
122 participants
Enrollment target
13
Study locations

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.

Conditions Studied

Malignant Neoplasm of Breast

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

2 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, categorized as NA. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 49-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (149% higher). The listed sponsor is Novian Health, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT03463954 reports 13 study locations spanning 6 distinct geographic areas - top geographies include Other, California, Connecticut.

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.

What interventions are being tested in trial NCT03463954?

The interventions under investigation include: Novilase Laser ablation (DEVICE).

Who is sponsoring clinical trial NCT03463954?

This trial is sponsored by Novian Health, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.