Clinical trials: Reconstructive Surgery
Breast Cancer, Mastectomy
Patient Activated Controlled Expansion (PACE) Trial
The purpose of this study is to determine whether a patient controlled tissue expander can improve the results and patient experience in breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Breast Reconstruction
- Trial name
- PACE (NCT01009008)
- Testing
- Patient Activated Controlled Expansion Device
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- AirXpanders, Inc.
Plastic Surgery, Reconstructive Surgery
STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use
This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold.
- Trial name
- NCT04195854
- Testing
- P4HB product
- Where
- 10 sites in United States
- Volunteers
- 1,183 people
- Sponsor
- C. R. Bard
Congenital Heart Disease
Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction
The study is a prospective, non-randomised, open label clinical study to assess the safety of the Bioabsorbable Pulmonary Valved (PV) conduit (PV-001) in subjects > 2 years and < 22 years of age, undergoing Right Ventricular…
- Trial name
- NCT02700100
- Testing
- Bioabsorbable Pulmonary Valved Conduit (PV-001)
- Where
- 3 sites in Hungary, Malaysia and 1 more
- Volunteers
- 12 people
- Sponsor
- Xeltis
Breast Implant; Complications, Infection or Inflammation
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal…
- Trial name
- NCT05744414
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- AlloSource
Mandibular Fractures, Facial Fracture
Stryker Facial iD Universal Plate Configurator: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Facial iD Universal Plate Configurator (UPC) implants in the clinical setting.
- Conditions
- Mandibular Fractures, Facial Fracture, Maxilla Fracture, Orthognathic Surgical Procedures
- Trial name
- UPC (NCT07245810)
- Testing
- Orthognatic surgery, Reconstructive maxillofacial surgery, Mandible and maxillofacial trauma surgery
- Where
- 2 sites in United States
- Volunteers
- 726 people
- Sponsor
- Stryker Craniomaxillofacial
Full-thickness Skin Defects, Degloving Injuries
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.
- Conditions
- Full-thickness Skin Defects, Degloving Injuries, Crush Injuries, Laceration of Skin
- Trial name
- NCT04091672
- Testing
- Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
- Where
- 18 sites in United States
- Volunteers
- 65 people
- Sponsor
- Avita Medical
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
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Arterial Occlusive Disease
A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients
The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.
- Trial name
- Reliable (NCT01746550)
- Testing
- MD-12-001 Stent
- Where
- 12 sites in Japan
- Volunteers
- 70 people
- Sponsor
- C. R. Bard
Mammaplasty, Breast Cancer
Motiva Flora® Aesthetic Breast Recon® Clinical Study
The present study will be based on a hybrid breast reconstruction approach with initial skin expansion using the Motiva Flora® Tissue Expander followed by a serial fat grafting session and a final step that includes the placement…
- Conditions
- Mammaplasty, Breast Cancer, Poland Syndrome
- Trial name
- NCT06146231
- Testing
- Motiva Flora® Tissue Expander
- Where
- 4 sites in Belgium, Colombia and 2 more
- Volunteers
- 66 people
- Sponsor
- Establishment Labs
Safety and Performance, Breast Tissue Expander
Post-marketing Clinical Monitoring of Safety and Performance of Breast Tissue Expander for Breast Reconstruction
The study investigates the safety and performance of Silimed® brand breast tissue expander in women born with indication for breast reconstruction.
- Trial name
- STEPS-R (NCT06981481)
- Testing
- Breast tissue expander
- Where
- 3 sites in Brazil
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Silimed Industria de Implantes Ltda
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
Precise Image (AI Reconstruction Feature of CT 5400 RT System)
Clinical Study of CT 5400 RT for Precise Image Validation
The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System
- Trial name
- NCT06589934
- Testing
- Precise Image
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Breast Reconstruction
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support and Repair in Breast Reconstruction
Prospective, single center, postmarket clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support and repair in breast reconstruction.
- Trial name
- NCT01914653
- Testing
- Silk surgical mesh
- Where
- Israel
- Volunteers
- 17 people
- Sponsor
- Sofregen Medical, Inc.
Acute Ruptures of the Anterior Cruciate Ligament
L-C Ligament Versus Hamstring Autograft for Primary ACL Reconstruction
The purpose of this study is to compare safety and efficacy outcomes of the L-C Ligament versus Hamstring Autograft for treatment of acute rupture of the ACL.
- Trial name
- NCT02183727
- Testing
- L-C Ligament, Hamstring Autograft
- Where
- Netherlands
- Volunteers
- 60 people
- Sponsor
- Soft Tissue Regeneration, Inc.
Deep Inferior Epigastric Perforator Flap Reconstruction
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep inferior epigastric perforator…
- Trial name
- NCT03481140
- Testing
- TissuGlu Surgical Adhesive
- Volunteers
- 58 people
- Sponsor
- Cohera Medical, Inc.
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
- Conditions
- Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions
- Trial name
- MINITAC (NCT04186481)
- Testing
- MINITAC Ti 2.0 suture anchor
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Smith & Nephew, Inc.
Heart Defects, Congenital
Xeltis Pulmonary Valved Conduit Safety and Performance Study
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or…
- Trial name
- NCT03405636
- Testing
- Xeltis Pulmonary Valved Conduit
- Where
- 4 sites in Hungary, Malaysia and 2 more
- Sponsor
- Xeltis
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Juxtarenal Abdominal Aortic Aneurysm
Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)
A prospective, multi-center, objective performance criteria clinical trial to evaluate the safety and efficacy of WeFlow-JAAA stent graft system manufactured by Hangzhou Endonom Medtech Co., Ltd.
- Trial name
- NCT05179967
- Testing
- WeFlow-JAAA Stent Graft System
- Where
- China
- Volunteers
- 106 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.