Clinical trials: Breast Reconstruction
Breast Augmentation, Breast Reconstruction
Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Revision of Augmentation or Reconstruction
- Trial name
- NCT00689871
- Testing
- Natrelle(TM) Silicone-Filled Breast Implants
- Where
- United States
- Volunteers
- 715 people, healthy volunteers welcome
- Sponsor
- Allergan Medical
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Mammoplasty, Postoperative Pain
Study of EXPAREL in Patients Undergoing Breast Augmentation
This is a Phase 4, prospective, open-label, non-randomized, sequential study with two treatment groups differing only in the technique used for EXPAREL administration (instillation or infiltration).
- Trial name
- NCT01582490
- Testing
- Instillation - EXPAREL, Infiltration - EXPAREL
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Postoperative Pain
Phase 2B Upper Extremity Nerve Block Study
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of…
- Trial name
- NCT03011333
- Testing
- HTX-011, Bupivacaine HCl without epinephrine
- Where
- 2 sites in United States
- Volunteers
- 243 people
- Sponsor
- Heron Therapeutics
Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or…
- Conditions
- Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Acquired Lymphedema, Congenital Lymphedema
- Trial name
- NCT01273909
- Testing
- Perforator Flap Breast Reconstruction, Vascularized Lymph Node Transfer
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- The National Institute of Lymphology
Breast Reconstruction, Revision Breast Reconstruction
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
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.
Seroma, Necrosis
Retrospective Analysis of Veritas in Breast Reconstruction
Retrospective data collection of the use of Veritas in breast reconstruction surgery
- Conditions
- Seroma, Necrosis, Infection
- Trial name
- RAVE (NCT01454713)
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Baxter Healthcare Corporation
Breast Reconstruction
Becker Continued Access Study
While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device.
- Trial name
- NCT01286870
- Testing
- Mentor Becker 25 Expander/Breast Implant, Mentor Becker 50 Expander/Breast Implant
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction
Clinical Evaluation of Neorepair™ Acellular Matrix in Immediate Implant-Based Breast Reconstruction
The study investigates the safety and performance of Silimed® brand acellular matriz in women born female with indication for breast reconstruction.
- Trial name
- Neo-Matrix (NCT07480421)
- Testing
- Acellular matrix
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Silimed Industria de Implantes Ltda
Blood Transfusion, Blood Transfusion, Autologous
A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.
The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional…
- Conditions
- Blood Transfusion, Blood Transfusion, Autologous, Orthopedic Procedures, Orthopedic Surgery
- Trial name
- NCT00270023
- Testing
- epoetin alfa
- Volunteers
- 112 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Breast Reconstruction
Melodi Matrix™ in Breast Reconstruction
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
- Trial name
- NCT06027996
- Testing
- Absorbable Antibacterial Matrix
- Where
- 10 sites in United States
- Volunteers
- 702 people
- Sponsor
- Melodi Health, Inc.
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 Female
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other…
- Trial name
- SCderm (NCT06553859)
- Testing
- No intervention conducts.
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- DOF Inc.
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
Mammoplasty
A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis
This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in…
- Trial name
- APPeaR (NCT03744013)
- Testing
- Fortiva® 1mm
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 87 people
- Sponsor
- RTI Surgical
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 Augmentation, Breast Reconstruction
Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants
This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Implant Revision
- Trial name
- NCT01785069
- Testing
- Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection
- Where
- 29 sites in United States
- Volunteers
- 355 people, healthy volunteers welcome
- Sponsor
- Allergan
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
Breast Cancer
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.
- Trial name
- XPAND-II (NCT02504424)
- Testing
- AeroForm Tissue Expander
- Where
- 8 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AirXpanders, Inc.