Clinical trials: Breast Reconstruction
Breast Augmentation, Breast Reconstruction
Sientra Post-Approval Study
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01639053
- Where
- United States
- Volunteers
- 5,498 people, healthy volunteers welcome
- Sponsor
- Tiger Biosciences, LLC.
Skin Barrier to Water Loss, Skin Health
Apple Peptide Complex for Post-Surgical and Aesthetic Skin Recovery
This clinical study evaluates a topical botanical formulation for supporting skin recovery following invasive and non-invasive aesthetic procedures.
- Conditions
- Skin Barrier to Water Loss, Skin Health, Skin Discoloration, Skin Irritation
- Trial name
- APC-SKIN (NCT07807085)
- Testing
- Apple Peptide Complex Post-Aesthetic Care Protocol
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Grow Out Oils Clinical Aromatherapy Company
Breast Augmentation, Breast Reconstruction
A Post-market Prospective Clinical Study of Eurosilicone Luna Mammary Implants
The goal of this observational, non-comparative study is to determine the frequency and rate of rupture and capsular contracture Baker III-IV of Eurosilicone Luna range of breast implants, over a 10-year period following surgical…
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision-Augmentation, Breast Reconstruction With Silicone Implants
- Trial name
- NCT07679594
- Testing
- Breast augmentation surgery, Breast reconstruction surgery
- Where
- 2 sites in France, Spain
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- GCA (Eurosilicone)
Tissue Expansion, Implant Based Breast Reconstruction
Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction
The conventional breast tissue expander used for breast reconstruction/ augmentation requires weekly or biweekly injections of saline through the skin and into an integrated port in the implant using a needle and syringe in order…
- Trial name
- NCT05975372
- Testing
- Blossom tissue expander, Standard tissue expansion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Stanford University
Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance
Safety and Performance of Motiva® Sizers
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures.
- Conditions
- Breast Implant; Complications, Breast Implantation; Methods, Safety and Performance, Mammaplasty, Breast Reconstruction
- Trial name
- NCT06274736
- Testing
- Motiva Sizer
- Where
- Costa Rica
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Establishment Labs
Breast Reconstruction
Acellular Dermal Matrix Investigation in Breast Reconstruction
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
- Trial name
- ADMIRE (NCT06456554)
- Testing
- Acellular Dermal Matrix (Cortiva Tissue Matrix)
- Where
- 13 sites in United States
- Volunteers
- 467 people, healthy volunteers welcome
- Sponsor
- RTI Surgical
Mastectomy, Mastectomy Patient
A Study on Pain After Breast Reconstruction
The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer.
- Conditions
- Mastectomy, Mastectomy Patient, Mastectomy and Breast Reconstruction, Breast Reconstruction
- Trial name
- NCT06627582
- Testing
- PROMIS Scale v2.0 - Pain Intensity 3a, PROMIS 29+2, PROMIS Scale v2.0 - Nociceptive Pain Quality 5a
- Where
- 7 sites in United States
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Mastectomy and Breast Reconstruction, Sexual Wellness
Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys. This data can support preoperative patient counselling and the prevention and care of adverse effects of…
- Trial name
- NCT07234461
- Testing
- Survey using a questionnaire.
- Where
- 19 sites in Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- European Institute of Oncology
Abdominoplasty, Breast Reduction
The Impact of Nutritional Optimization to Enhance Postoperative Outcomes Using the R-Support Supplements
The aim of this pilot study is to evaluate the potential benefits of nutrient supplementation on post-operative recovery for patients undergoing certain types of surgery, compared to those who do not receive such supplementation.
- Conditions
- Abdominoplasty, Breast Reduction, Autologous Breast Reconstruction, Body Contouring Surgery
- Trial name
- R-Support (NCT06601868)
- Testing
- R-Support Prepare & After nutritional supplement
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
Braest Cancer, Breast Reconstruction
Evaluating the Effectiveness of an Early Exercise Program After Breast Reconstruction
Breast reconstruction is an important step and option after mastectomy and can help improve the quality of life of breast cancer patients.
- Trial name
- NCT06552650
- Testing
- Exercise, Usual Care
- Where
- South Korea
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Breast Reconstruction, Patient Education
Educational Session To Optimize Patient's Breast Reconstruction Experience at McMaster
This pilot study uses a randomized controlled trial design to introduce an educational session for breast reconstruction patients. Participants will be randomly assigned to the (1) control group or the (2) experimental group.
- Trial name
- RESTORE (NCT03743753)
- Testing
- Experimental
- Where
- 2 sites in Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- McMaster University
Mammoplasty, Scarring
A Study of Granexin® Gel for the Reduction of Scar Formation in Surgical Wounds Following Bilateral Anchor Incision Breast Surgery
The purpose of this study is to evaluate effectiveness of Granexin® gel in reducing scar formation in surgical incisional wounds.
- Conditions
- Mammoplasty, Scarring, Scar, Breast Reconstruction
- Trial name
- NCT04331080
- Testing
- Granexin® gel 100 μM, Granexin® gel 200 μM, Vehicle gel
- Where
- 11 sites in United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- Xequel Bio, Inc.
Breast Cancer, Breast Reconstruction
Nipple Sparing Mastectomy - Cosmetic Outcomes
The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.
- Conditions
- Breast Cancer, Breast Reconstruction, Cosmesis
- Trial name
- NCT01002014
- Testing
- Nipple Sparing Mastectomy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
Breast Augmentation, Breast Reconstruction
Evaluation of the Safety and Performance of ESTYME® MATRIX Round and Anatomical Breast Implants - EMMIE Study
The study will evaluate the safety and performance of the ESTYME® MATRIX Round and Anatomical Silicone Gel-Filled Breast Implants in the breast augmentation and reconstruction.
- Trial name
- EMMIE (NCT03386682)
- Testing
- ESTYME® MATRIX Breast Implants
- Where
- 8 sites in France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
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 Augmentation, Breast Reconstruction
NATRELLE® 410 X-Style and L-Style Breast Implants Continued Access Study
This study is a prospective, multicenter, nonrandomized study to provide access to and evaluate 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
- NCT01870869
- Testing
- Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection
- Where
- 58 sites in United States
- Volunteers
- 1,951 people, healthy volunteers welcome
- Sponsor
- Allergan
Breast Reconstruction, Breast Augmentation
Mentor MemoryGel Post-Approval Study
In November 2006, U.S. Food and Drug Administration (FDA) approved Mentor's MemoryGel silicone gel-filled breast implants for use in women who are undergoing primary or revisional breast augmentation and primary or revisional…
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- MGPAS (NCT00756652)
- Testing
- Mentor Silicone Gel-Filled Breast Implants, Saline Breast Implants
- Volunteers
- 42,491 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Reconstruction
Direct to Implant Breast Reconstruction Based Pre- or Retropectoral
The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two…
- Trial name
- NCT03143335
- Testing
- Retropectoral immediate breast reconstruction, Prepectoral immediate breast reconstruction
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Breast Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC