Clinical trials: Mastectomy
Prophylactic Nipple Sparing Mastectomy (NSM)
Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of…
- Trial name
- PREVENT (NCT05251285)
- Testing
- Nipple-Sparing Mastectomy
- Where
- 2 sites in France, Italy
- Volunteers
- 7 people
- Sponsor
- Intuitive Surgical
Mastectomy
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and…
- Trial name
- PRECISE (NCT00943605)
- Testing
- Scalpel and Traditional Electrosurgery, PEAK PlasmaBlade
- Where
- 4 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic Surgical Technologies
Breast Cancer
Randomized Study of Combination Chemotherapy With or Without Focused Microwave Thermotherapy Before Surgery in Treating Women With Large Breast Cancer Tumors
The purpose of this randomized Phase III study is to determine whether preoperative focused microwave heat treatment and chemotherapy combined are more effective than preoperative chemotherapy alone in the treatment of large…
- Trial name
- Medifocus301 (NCT01204801)
- Testing
- Focused Microwave Thermotherapy, Chemotherapy (control)
- Where
- 2 sites in United States, Canada
- Volunteers
- 238 people
- Sponsor
- Medifocus, Inc.
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
Breast Surgery Recovery: The Clinical and Psychosocial Impact of THEYA Recovery Range
A randomised interventional comparative control study will be undertaken to compare the THEYA Recovery Range postoperatively for patients undergoing wider lumpectomies, partial mastectomies and total mastectomies to current…
- Trial name
- NCT02593890
- Testing
- THEYA Recovery Range
- Volunteers
- 100 people
- Sponsor
- Claire Kelly
Nipple Necrosis, Nipple Graft Loss
Plexaa For Preconditioning: Gender Affirming Mastectomy
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy.
- Trial name
- P4PGAM (NCT06502353)
- Testing
- BLOOM43
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Plexaa Ltd
Breast Cancer
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast…
- Trial name
- NCT01823107
- Testing
- Meso BioMatrix Device
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Kensey Nash Corporation
Breast Cancer Female
Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer
This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in…
- Trial name
- NCT04397185
- Testing
- Breast Cancer Locator (BCL) guided partial mastectomy, Wire Localized (WL) partial mastectomy
- Where
- 23 sites in United States, Austria and 2 more
- Volunteers
- 480 people
- Sponsor
- CairnSurgical, Inc.
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.
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 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.
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
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
- Trial name
- NCT06575192
- Testing
- ARTIA Reconstructive Tissue Matrix
- Where
- 23 sites in United States
- Volunteers
- 264 people
- Sponsor
- AbbVie
Breast Cancer, Mastectomy
Patient Activated Controlled Expansion (PACE) Trial
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Breast Reconstruction
- Trial name
- PACE (NCT01009008)
- Testing
- Patient Activated Controlled Expansion Device
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- AirXpanders, Inc.
Breast Cancer, Lumpectomy
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing…
- Conditions
- Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection, Lymphatic Leakage
- Trial name
- NCT00161980
- Testing
- Fibrin Sealant VH S/D, Surgical intervention alone without Fibrin Sealant VH S/D application
- Where
- 8 sites in Austria, France and 2 more
- Sponsor
- Baxter Healthcare Corporation
Cancer, Breast
Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
- Trial name
- NCT02958449
- Testing
- Test - Standard Closure with TissuGlu Surgical Adhesive
- Where
- 10 sites in Germany, United Kingdom
- Volunteers
- 77 people
- Sponsor
- Cohera Medical, Inc.
Mammaplasty, Mastectomy
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro…
- Conditions
- Mammaplasty, Mastectomy, Lumpectomy
- Trial name
- NCT00466765
- Testing
- Brava Autologous Fat Transfer System
- Where
- 2 sites in United States
- Volunteers
- 589 people, healthy volunteers welcome
- Sponsor
- Brava
Mastectomy, Segmental, Breast Neoplasm Malignant Female
Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy
The goals of this clinical trial are: demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions demonstrate the safety and performance of REGENERA in terms of investigator's…
- Trial name
- NCT05941299
- Testing
- REGENERA breast implant implantation
- Where
- 9 sites in Italy, Spain
- Volunteers
- 92 people
- Sponsor
- Tensive SRL
Mastectomy and Breast Reconstruction
Efficacy Study of Single Stage Breast Reconstruction in Female Participants With Mastectomy
The purpose of this study was to compare the efficacy of immediate single-stage post-mastectomy breast reconstruction with Strattice Reconstructive Tissue Matrix (Strattice) as compared to immediate two-stage post-mastectomy…
- Trial name
- ESSBR (NCT01910298)
- Testing
- Breast Reconstruction, Direct to Implant (DTI) with Strattice™, Two Stage Breast Reconstruction
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 131 people
- Sponsor
- LifeCell
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