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NCT01969448 · ClinicalTrials.gov registry record · NA
Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT01969448: Completed NA study, sponsored by Washington University School of Medicine.
NCT01969448 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01969448, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study Summary
The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.
Primary Outcome
* Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion. * The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and com
Interventions
- DRUG Indocyanine Green
- PROCEDURE Inframammary Fold Incision or Lateral Radial Incision
- PROCEDURE Lateral Radial Incision
- PROCEDURE Inframammary Fold Incision
- DEVICE Laser-assisted fluorescence angiography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2013-03-28 |
| Est. Completion | 2017-04-17 |
| Phase | NA |
What the finished NCT01969448 record still lists
NCT01969448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Indocyanine Green is the first listed.
NCT01969448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01969448 about?
NCT01969448 is a clinical study titled "Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction". The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will b...
What is the current status of trial NCT01969448?
This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2013-03-28. Estimated completion is 2017-04-17.
What interventions are being tested in trial NCT01969448?
The interventions under investigation include: Indocyanine Green (DRUG), Inframammary Fold Incision or Lateral Radial Incision (PROCEDURE), Lateral Radial Incision (PROCEDURE), Inframammary Fold Incision (PROCEDURE), Laser-assisted fluorescence angiography (DEVICE).
Who is sponsoring clinical trial NCT01969448?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01969448's enrollment target sits among peer trials
79 1060th of 2000 higher than 941 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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