Clinical trials: Mastectomy
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
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
Mastectomy; Lymphedema
ConMed HelixAR™ ElectroSurgical Generator With Argon Beam Coagulation Technology Study
A PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY TO EVALUATE DEVICE EFFICACY BETWEEN THE HELIXAR ELECTROSURGICAL GENERATOR (HEG) VS. CONVENTIONAL ELECTROSURGICAL COAGULATION (CEC) FOR CUTTING AND/OR COAGULATION OF TISSUE DURING…
- Trial name
- CHEST (NCT04165525)
- Testing
- Ablation
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- SurgiQuest, Inc.
Breast Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
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 Female, Breast Cancer
Robotic vs. Open NSM for Early Stage Breast Cancer
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease
- Trial name
- SP NSM (NCT05720039)
- Testing
- Robotic NSM, Open NSM
- Where
- 15 sites in United States
- Volunteers
- 204 people
- Sponsor
- Intuitive Surgical
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 Neoplasms
The Breast Surgery EnLight and LightPath Imaging System Study
This study will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath…
- Trial name
- NCT02151071
- Testing
- EnLight, LightPath
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Lightpoint Medical Limited
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 Cancer, DCIS
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by…
- Conditions
- Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
- Trial name
- NCT05900986
- Testing
- LS301-IT 0.025 mg/kg, LS301-IT 0.05 mg/kg, LS301-IT 0.075 mg/kg
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Integro Theranostics
Breast Cancer, Reconstructive Breast Surgery
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
- Trial name
- NSM (NCT01796977)
- Testing
- OxyGenesys Dissolved Oxygen Dressing, Standard Gauze Dressing
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halyard Health
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
Patients With Breast Cancer Requiring Mastectomy and Suitable for Reconstruction
Impact of ADM in Reduction of Surgical Complexity of Breast Reconstructions With Implants (Nava)
The objective of this study is to demonstrate that acellular dermal matrix, Strattice™ Reconstructive Tissue Matrix, can reduce the surgical complexity and post-operative pain of breast reconstructions with implants by avoiding…
- Trial name
- NCT01853436
- Testing
- Strattice™ Reconstructive Tissue Matrix
- Where
- Italy
- Volunteers
- 36 people
- Sponsor
- LifeCell
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
Nipple Sparing Mastectomy
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
- Trial name
- NCT03892980
- Testing
- Nipple-Sparing Mastectomy
- Where
- 6 sites in United States
- Volunteers
- 145 people
- Sponsor
- Intuitive Surgical
Prophylactic Mastectomy
Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue
This is a single-arm, prospective study of a radiofrequency ablation device on the excised breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by the device will be analyzed histologically.
- Trial name
- NCT02614885
- Testing
- RFA
- Volunteers
- 11 people
- Sponsor
- Innoblative Designs, Inc.
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
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.