Clinical trials: Post Mastectomy
Reconstructive Surgical Procedures
The SurgiMend PRS Retrospective Study
The SurgiMend® PRS Retrospective Study will evaluate the performance and safety of SurgiMend® PRS and SurgiMend® PRS Meshed when used for soft tissue reinforcement under the product's indications for use.
- Trial name
- NCT05182177
- Testing
- SurgiMend PRS
- Where
- 6 sites in Italy, Switzerland and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Pain, Postoperative
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores
This is a multiple center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with high Pain Catastrophizing Scale…
- Trial name
- NCT04104919
- Testing
- Brivoligide Injection 660 mg/6 mL
- Sponsor
- Adynxx, Inc.
Breast Cancer
Post-op Outcomes of Enhanced Energy Delivery Dissection for Mastectomy With Immediate Breast Reconstruction
Principal Investigator: Sheldon Feldman, MD Co-Principal Investigator: Mohamad Sebai, MD Department of Surgery, Montefiore Medical Center - Einstein College of Medicine Title Pilot Study: Post-operative outcomes of enhanced…
- Trial name
- NCT03627442
- Testing
- Mastectomy with PhotonBlade, Mastectomy with Bovie
- Volunteers
- 15 people
- Sponsor
- Invuity, Inc.
Breast Cancer Female
Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection
Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish.
- Trial name
- Quilting (NCT03902977)
- Testing
- quilting, conventional suture
- Where
- Switzerland
- Volunteers
- 10 people
- Sponsor
- Lindenhofgruppe AG
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 Cancer
Immediate Postmastectomy Breast Reconstruction (Strattice Breast)
This prospective, multicenter, open-label study will assess the clinical outcomes of the LTM product in three planned analyses. The primary objective of this study is to prospectively assess the clinical outcomes associated with…
- Trial name
- NCT00619762
- Testing
- LTM - a porcine-based surgical mesh
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- LifeCell
Peripheral Nerve Block Procedure
Prospective Post-market Evaluation of an Echogenic Catheter
Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups. Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound…
- Trial name
- EchoCath (NCT02136446)
- Testing
- EchoGlo Nerve Block Catheter, Pajunk® Nerve Block Catheter
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Smiths Medical, ASD, Inc.
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
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
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
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
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
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)
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 Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates