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NCT02456649 · ClinicalTrials.gov registry record · NA
Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe
A NA study, sponsored by Huntington Memorial Hospital.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT02456649: Completed NA study, sponsored by Huntington Memorial Hospital.
NCT02456649 is a NA study that has completed, run by Huntington Memorial Hospital. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02456649, a NA study, has completed, sponsored by Huntington Memorial Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study Summary
The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple studies have demonstrated the association between positive lumpectomy margins and an increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation. Studies report 20-40% of lumpectomy procedures result in one or more involved (positive) surgical margins, leading to the need for further surgery, emotional distress, poorer cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative margin assessment techniques include specimen Xray, gross pathology, frozen section, and touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative assessment of the presence of tumor at the lumpectomy margin. In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.
Interventions
- DEVICE MarginProbe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-09 |
| Phase | NA |
What the finished NCT02456649 record still lists
NCT02456649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which MarginProbe is the first listed.
NCT02456649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02456649 about?
NCT02456649 is a clinical study titled "Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe". The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States unde...
What is the current status of trial NCT02456649?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2015-03. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02456649?
The interventions under investigation include: MarginProbe (DEVICE).
Who is sponsoring clinical trial NCT02456649?
This trial is sponsored by Huntington Memorial Hospital, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02456649's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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