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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: Recruiting NA study of Malignant Neoplasm of Breast, sponsored by Novian Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Efficacy: Rate of complete ablation by Novilase laser ablation
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2023-08-09 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
What NCT03463954 shows while recruiting
NCT03463954 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 49-participant average among 10 other Malignant Neoplasm of Breast trials with a reported enrollment target (149% higher).
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 lists 13 locations in 6 states (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.
Learn More About Clinical Trials
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Where NCT03463954's enrollment target sits among peer trials
122 2nd of 10 the highest of 10 other Malignant Neoplasm of Breast trials
participants (enrollment target), bucketed by value
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