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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 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 79 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01969448
The ClinicalTrials.gov registry entry for NCT01969448 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Indocyanine Green is the first listed.
NCT01969448 reports 0 study locations.
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.
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