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NCT04625621: EXCLUFAT
Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life
trial in Breast Cancer in 118 participants. Completed in 5 February 2021.
5 January 2021
Quick facts
| Lead sponsor | Institut Cancerologie de l'Ouest |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 118 |
| Start date | 26 November 2020 |
| Primary completion | 5 January 2021 |
| Estimated completion | 5 February 2021 |
| Sites | 1 location across France |
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Mastectomy; Lymphedema — all drugs for Mastectomy; Lymphedema →
Sponsor
Institut Cancerologie de l'Ouest — full company profile →
Who can join
18 and older, female only, with Breast Cancer or Mastectomy; Lymphedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative treatment is possible in the majority of cases, there is still an indication for mastectomy in about 30% of cases. Currently, only 30% of women who have undergone a mastectomy choose reconstruction. The primary objective of breast reconstruction from a surgical point of view is to leave as few aesthetic and functional after-effects as possible while meeting the personal wishes of each woman according to her morphological, tissue and vascular characteristics. There are currently 2 major surgical procedures for breast reconstruction: breast implant reconstructions and autologous reconstructions. Breast reconstruction by prosthesis is the simplest and most widely used technique but, the controversies concerning implants with the PIP breast prostheses scandal in 2010 and more recently the anaplastic lymphoma scandal have tarnished the image of this type of reconstruction. Alternatives to breast implants have been developed: autologous reconstructions using first pedicled tissue flaps, then free flaps, techniques that allow a more natural, more satisfactory aesthetic result with an evolution that follows the patient's own morphology but requiring specific training in microsurgery and not without postoperative complications. Since 1999, the investigators have witnessed the evolution of another autologous technique, that of lipomodulin. Initially used to improve the results of reconstructions and the aesthetic sequelae of conservative treatments, it is now used as an exclusive reconstruction technique. Easily reproducible and offering several advantages, reconstruction by exclusive lipomodulin is increasingly appreciated by patients. However, this increasingly practiced technique presents specific problems and this is what the investigators want to evaluate in this study. The main objective of this study is to evaluate the practices within our establishment regarding breast reconstruction by exclusive lipomodulin in terms of feasibility. The secondary objectives are the evaluation of the cosmetic result and the quality of life of these patients after this type of reconstruction.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04625621
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04625621 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut Cancerologie de l'Ouest
- Last refreshed: 13 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04625621.
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