Clinical trial · Observational
SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
NCT01315119CI-TRIAL-00053143completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPY Intra-Operative Angiography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
- timeFrame
- During surgery
- measure
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
- timeFrame
- Immediately post operative
- measure
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
- timeFrame
- 2 weeks
- measure
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
- timeFrame
- 1 month
- measure
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 3.1.0 Ability to understand and the willingness to sign a written informed consent document. 3.1.1 Signed written informed consent. 3.1.2 Women with local or regional recurrences after previous breast conserving surgery. 3.1.3 Women undergoing delayed post mastectomy reconstruction. 3.1.4 Women undergoing prophylactic mastectomy. 3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction. 3.1.6 Women of 18 years of age or older. 3.1.7 ECOG or Karnofsky Performance Status 0,1,2. 3.1.8 Basic Metabolic Panel within 6 months 3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements. Exclusion Criteria: 3.2.1 History of liver or kidney failure will not be eligible. 3.2.2 Allergies to iodine containing products will not be eligible. 3.2.3 Women who are pregnant will not be eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.