Clinical trial · Interventional
Treatment of Benign Breast Deformities and Post-Segmental Mastectomy Breast Deformities With Autologous Fat Grafting (AFT)
NCT01756092CI-TRIAL-00024381withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Because funding was not secured, the study was never initiated. 0 subjects enrolled
Summary
Brief summary (as posted)
The investigators will assess changes in breast appearance, graft retention and quality of life over one year in patients who have received direct autologous adipose tissue injection for the treatment of objectionable post-surgical breast deformities. These patients have undergone the resection of breast tissue to treat either benign or malignant breast disease.
Conditions
Conditions (3)
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 |
| Lumpectomy | — | UNRESOLVED | — |
| Mastectomy, Segmental | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Fat Graft | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous Fat Graft
- description
- Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.
- interventionNames
- Procedure: Autologous Fat Graft
Primary outcomes (1)
- measure
- Breast Tissue Volume/Appearance (Graft Retention)
- timeFrame
- Through 12 months following procedure
- description
- Assess breast appearance and soft tissue volume before and after autologous fat grafting utilizing 2D / 3D digital photography and a physician rating scale to determine graft retention through 12 months following fat grafting procedure.
Secondary outcomes (1)
- measure
- Patient Satisfaction
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 through 70 years of age inclusive and able to provide informed consent and * Subject is 6 months post chemotherapy or radiation treatment and is scheduled for physician evaluation for a standard of care breast fat graft procedure. * Per PI's discretion is stable post-surgery or who has a benign breast deformity or post segmental breast deformity * Willing and able to comply with the study schema for research procedures. Exclusion Criteria: Age less than 18 years * Inability to provide informed consent * Active chemotherapy or radiation therapy treatment for cancer diagnosis * Not clinically stable to have a surgical intervention * Active infection anywhere in the body * Known coagulopathy * Pregnancy * Per the PI's discretion, subject is not a candidate for participation in this clinical trial.
References
Publications (16)
- BACKGROUNDRigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71. PMID 17415234
- BACKGROUNDBircoll M, Novack BH. Autologous fat transplantation employing liposuction techniques. Ann Plast Surg. 1987 Apr;18(4):327-9. doi: 10.1097/00000637-198704000-00011. PMID 3579174
- BACKGROUNDIllouz YG. The fat cell "graft": a new technique to fill depressions. Plast Reconstr Surg. 1986 Jul;78(1):122-3. No abstract available. PMID 3725947
- BACKGROUNDMatsudo PK, Toledo LS. Experience of injected fat grafting. Aesthetic Plast Surg. 1988 Feb;12(1):35-8. doi: 10.1007/BF01570383. PMID 3376783
- BACKGROUNDColeman SR. Facial augmentation with structural fat grafting. Clin Plast Surg. 2006 Oct;33(4):567-77. doi: 10.1016/j.cps.2006.09.002. PMID 17085224
- BACKGROUNDEllenbogen R. Free autogenous pearl fat grafts in the face--a preliminary report of a rediscovered technique. Ann Plast Surg. 1986 Mar;16(3):179-94. doi: 10.1097/00000637-198603000-00001. PMID 3273033
- BACKGROUNDColeman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9. PMID 17312477
- BACKGROUNDSpear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. doi: 10.1097/01.prs.0000181509.67319.cf.