Clinical trials: Breast Lumpectomy
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 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.
Breast Cancer Female
Low Energy Dissection Vs. Electrocautery in Lumpectomy Shaved Surgical Margins
The purpose of this study is to compare the qualitative severity and depth of dissection devices' associated thermal artifact in breast lumpectomy shaved margins between the use of electrocautery and low thermal energy…
- Trial name
- NCT03718442
- Testing
- PhotonBlade vs Bovie for lumpectomy shaved surgical margins
- Volunteers
- 20 people
- Sponsor
- Invuity, 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.
Breast Cancer
MarginProbe 2.0 Data Collection Protocol
Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen.
- Trial name
- NCT05377229
- Testing
- MarginProbe2.0
- Where
- 9 sites in United States, Israel
- Volunteers
- 398 people
- Sponsor
- Dilon Medical Technologies Ltd.
Benign Breast Disease
REGENERA Implant in Excised Non-Malignant Breast Lesions
The purpose of this First-in-Human pilot study is to evaluate the safety and performance of REGENERA breast implant in a selected cohort of patients with non- malignant breast lesions treated with excision or lumpectomy in whom…
- Trial name
- NCT04131972
- Testing
- REGENERA
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Tensive SRL
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