Clinical trials: Breast Lumpectomy
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.
Breast Cancer
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
The purpose of this study is to provide prospective evidence in the US population of the frequency of skin discoloration and Sentinel Lymph Node detection rate in patients who have recevied Magtrace for Sentinel Lymph Node Biopsy…
- Trial name
- MAGProm (NCT06610539)
- Where
- 2 sites in United States
- Volunteers
- 184 people
- Sponsor
- Endomagnetics Ltd.
TNBC - Triple-Negative Breast Cancer
Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient [API]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical…
- Trial name
- NCT07723469
- Testing
- BCS + SRG-514, BCS
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- SURGE Therapeutics
Breast Diseases
REGENERA Implant in Localized Non-malignant Breast Lesions Treated by Excision or Lumpectomy - Long-term Follow-up
In a previous first-in-human (FIH) study we assessed safety and performance of REGENERA in 15 patients treated for breast deformities following excision or lumpectomy.
- Trial name
- NCT05533099
- Testing
- Observational study
- Where
- Italy
- Volunteers
- 14 people
- Sponsor
- Tensive SRL
Breast Cancer
Investigation of Novel Surgical Imaging for Tumor Excision
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in…
- Trial name
- INSITE (NCT03686215)
- Testing
- Study Device Arm
- Where
- 14 sites in United States
- Volunteers
- 406 people
- Sponsor
- Lumicell, 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
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
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion…
- Trial name
- NCT01699867
- Testing
- Optical coherence tomography
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Diagnostic Photonics, Inc.
Female Breast Carcinoma, Female Ductal Carcinoma In Situ
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS.
- Trial name
- 007 (NCT02540330)
- Testing
- Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Atossa Therapeutics, Inc.
Radiodermatitis; Acute
A Study of GR1014 Cutaneous Gel for the Prevention of Skin Reactions Caused by Radiation Therapy for Breast Cancer
This clinical trial is testing a new skin gel called GR1014-CG to evaluate its safety and see if it can help prevent or reduce skin irritation (such as redness, soreness, etc.) caused by radiation therapy (RT) after…
- Trial name
- GuARD (NCT07192588)
- Testing
- GR1014-CG 2.4%, Vehicle Gel, Radiation Therapy
- Where
- 4 sites in France, United Kingdom
- Volunteers
- 273 people
- Sponsor
- Graegis Pharmaceuticals Ltd
Breast Neoplasm
SAVI SCOUT Clinical Evaluation Study
The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide real-time guidance during localized excisional biopsy or…
- Trial name
- NCT02370082
- Testing
- Localization of breast lesion
- Volunteers
- 150 people
- Sponsor
- Cianna Medical, Inc.
Breast Cancer
Assessment of Lumpectomy Margins With the Histolog Scanner in Comparison With Intraoperative Imaging Techniques
Study to assess the capability of using the Histolog Scanner, a recent large field-of-view confocal laser scanning medical imaging device for the breast cancer detection in fresh lumpectomy margins.
- Trial name
- Polarhis (NCT05118568)
- Testing
- Histolog Scanner
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- SamanTree Medical SA
Breast Cancer
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality…
- Trial name
- PRECISE (NCT00960154)
- Testing
- PEAK PlasmaBlade, Traditional Electrosurgery with scalpel
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Surgical Technologies
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
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, Carcinoma
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer
PRINCIPAL INVESTIGATORS Rakesh Patel, MD- Radiation Oncologist Peter Beitsch, MD- Breast Surgeon REGISTRY DESIGN Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in…
- Conditions
- Breast Cancer, Carcinoma, Lumpectomy, Ductal Carcinoma in Situ
- Trial name
- EXIBT (NCT00742222)
- Testing
- Electronic Brachytherapy, Intracavitary accelerated partial breast irradiation
- Where
- 8 sites in United States
- Volunteers
- 63 people
- Sponsor
- Xoft, Inc.
Breast Cancer
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast…
- Trial name
- NCT05456373
- Testing
- ClearEdge device
- Where
- United States
- Volunteers
- 288 people
- Sponsor
- LS BioPath
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.
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
Breast Cancer, Neoadjuvant Therapy
Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
- Trial name
- NCT04440982
- Testing
- LUM015, Lum Imaging System
- Where
- 6 sites in United States
- Volunteers
- 98 people
- Sponsor
- Lumicell, Inc.