Clinical trials: Breast Reconstruction Following Mastectomy
Pre-Pectoral Breast Reconstruction Following Mastectomy
Retrospective Study of AlloMend Acellular Dermal Matrix (ADM) Allograft and Pre-Pectoral Breast Reconstruction
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
- Trial name
- NCT06853964
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- AlloSource
Breast Reconstruction After Mastectomy
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well…
- Trial name
- PRO-BRA (NCT01885572)
- Testing
- TiLOOP Bra
- Where
- 8 sites in Germany
- Volunteers
- 267 people
- Sponsor
- Pfm Medical Mepro Gmbh
Breast Reconstruction Following Mastectomy
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data…
- Trial name
- NCT05031962
- Testing
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Where
- 10 sites in France
- Volunteers
- 112 people
- Sponsor
- Meccellis Biotech
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Breast Cancer Female, Breast Reconstruction
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
- Trial name
- SCderm (NCT06555692)
- Testing
- Transplant acellular dermal matrix(ADM)
- Where
- South Korea
- Volunteers
- 120 people
- Sponsor
- DOF Inc.
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
BIOCHROMADERM® PMCF STUDY
The goal of this observational study is to: To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation; To confirm the…
- Trial name
- NCT07261904
- Where
- 3 sites in France
- Volunteers
- 115 people
- Sponsor
- Laboratoires BIOTIC Phocea
Breast Neoplasms, Carcinoma, Ductal, Breast
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy
A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Mammaplasty, Mastectomy, Segmental, Lumpectomy, Breast Reconstruction,
- Trial name
- RESTORE-2 (NCT00616135)
- Testing
- ADRC-Enhanced Autologous Fat Transplant
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 71 people
- Sponsor
- Cytori Therapeutics
Breast Cancer
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.
- Trial name
- NCT01959867
- Testing
- SurgiMend® PRS, No Intervention
- Sponsor
- Integra LifeSciences Corporation
Pre-Pectoral Breast Reconstruction Following Single or Double Mastectomy
AlloMend Acellular Dermal Matrix Allograft in Pre-Pectoral Breast Reconstruction
This is a single-center, retrospective study which will be used to describe and evaluate the effectiveness of AlloMend® Acellular Dermal Matrix allograft for patients that have undergone Pre-Pectoral Breast Reconstruction surgery…
- Trial name
- NCT06512259
- Testing
- AlloMend® Acellular Dermal Matrix allograft
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- AlloSource
Post-Mastectomy Breast Deformity (Disorder)
Investigate Wound Healing, Aesthetics & Pt Satisfaction Post NAC Reconstruction Using a Decellularized Donor NAC Graft
To evaluate the wound healing response following nipple-areolar complex (NAC) reconstruction with a decellularized donor NAC graft (DCLNAC)
- Trial name
- NCT05484934
- Testing
- Regenerative post mastectomy surgery
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- BioAesthetics
Breast Cancer Female, Breast Cancer Prevent
First-in-human, Study of MATTISSE® Tissue Engineering Chamber in Adult Female Patients Undergoing Breast Reconstruction After Mastectomy for Cancer
This study is a first in human, two-stage single arm non-comparative study of safety and performance. The aim of the study is to asses the safety and the clinical performance of a new device : the MATTISSE tissu engineering…
- Conditions
- Breast Cancer Female, Breast Cancer Prevent, Breast Reconstruction
- Trial name
- TIDE (NCT05460780)
- Testing
- MATTISSE TEC
- Where
- 3 sites in France, Georgia
- Volunteers
- 50 people
- Sponsor
- Quanta Medical
Breast Asymmetry Between Native Breast and Reconstructed Breast
Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation
This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast…
- Trial name
- NCT02649283
- Testing
- OrbiSymm device, Breast symmetrisation
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Orbix Medical Ltd.
Breast Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)