Clinical trials: Reconstruction
Peripheral Nerve Injury Digital Nerve Hand
Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the…
- Trial name
- NCT03673449
- Testing
- SilkBridge
- Where
- Switzerland
- Volunteers
- 4 people
- Sponsor
- Silk Biomaterials srl
Anterior Cruciate Ligament Reconstruction
Effectiveness of Kneehab in Strengthening the Quadriceps of Patients Post Anterior Cruciate Ligament (ACL) Reconstruction
Prospective, controlled, randomized, single blind study in patients undergoing rehabilitation following anterior cruciate ligament reconstruction. 96 patients were randomly assigned to one of three groups.
- Trial name
- NMES (NCT00737750)
- Testing
- Kneehab, Poli-Stim, Control
- Where
- Germany
- Volunteers
- 131 people
- Sponsor
- Bio-Medical Research, Ltd.
Brain Aneurysm
Safety Study of the PulseRider® in Patients Undergoing Treatment for Bifurcation Intracranial Aneurysms
This is a prospective multi-center, single arm, non-randomized study. It is designed to evaluate the safety of the PulseRider® in patients undergoing treatment for bifurcation intracranial aneurysms.
- Trial name
- AWARD (NCT02435823)
- Testing
- PulseRider
- Where
- Austria
- Volunteers
- 35 people
- Sponsor
- Pulsar Vascular
Vascular Injury, Arterial Injury
Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair
The goal of this post-marketing observational study is to further assess the long-term safety and efficacy of Symvess in a real-world setting in adult patients with extremity arterial injury.
- Conditions
- Vascular Injury, Arterial Injury, Trauma Injury
- Trial name
- NCT07762794
- Testing
- Acellular Tissue Engineered Vessel
- Volunteers
- 125 people
- Sponsor
- Humacyte, Inc.
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.
Peri-implantitis
Reconstruction of Peri-implant Osseous Defects: A Randomized Trial
The purpose of this randomized trial was to compare reconstructive surgery of advanced peri-implant intra-osseous defects with porous titanium granules (PTG/Test) to open flap debridement (OFD/Control) in a non-submerged…
- Trial name
- NCT02406001
- Testing
- Tigran PTG, Surgical intervention
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Tigran Technologies AB
Breast Cancer
Retrospective Data Collection on the Use of Motiva Flora TE in Breast Reconstruction
The Motiva Flora® TE are intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and are not intended for use beyond six (6) months.
- Trial name
- NCT05459064
- Testing
- Motiva Flora TE
- Where
- 2 sites in Belgium, Spain
- Volunteers
- 144 people
- Sponsor
- Establishment Labs
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
Peripheral Vascular Disease
A Study on the Use of CorMatrix® ECM® for Femoral Arterial Reconstruction
To gather information on the use of CorMatrix ECM for Vascular Repair in the reconstruction of the femoral artery.
- Trial name
- PERFORM (NCT02418156)
- Testing
- CorMatrix ECM for Vascular Repair
- Volunteers
- 38 people
- Sponsor
- Elutia Inc.
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.
Aortic Arch Disease
Prospective, Multicenter, Single-Arm Study of Aortic Arch Pathology Reconstruction
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with…
- Trial name
- NCT07139912
- Testing
- Thoracic Aortic Multi-Branch Stent Graft System
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
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 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
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
Great Vessel Reconstruction, Peripheral Vessel Reconstruction
Post-Market Registry in Europe and US for the Use of VascuCelTM
This is a post-market, multi-centre, open-label registry designed to collect prospective safety and performance data on the use of VascuCel in patients who require great vessel reconstruction, peripheral vascular reconstruction…
- Conditions
- Great Vessel Reconstruction, Peripheral Vessel Reconstruction, Suture Line Buttressing
- Trial name
- VascuCel (NCT04906824)
- Testing
- great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
- Where
- 5 sites in United States, Italy
- Volunteers
- 100 people
- Sponsor
- LeMaitre Vascular
Reconstructive Surgical Procedures
A Retrospective Assessment of OviTex PRS (OviTex)
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast…
- Trial name
- PRS (NCT05736848)
- Testing
- OviTex® PRS
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tela Bio Inc
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
Tissue Repair, Soft Tissue Reconstruction
Urinary Bladder Matrix (UBM) Registry
The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products.
- Conditions
- Tissue Repair, Soft Tissue Reconstruction, Wound Management, Pressure Ulcer (PU)
- Trial name
- NCT07805798
- Testing
- Urinary Bladder Matrix (UBM) Products
- Volunteers
- 300 people
- Sponsor
- Integra LifeSciences Corporation
Medial Patellofemoral Dislocation
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction
This is a Post Market Clinical Follow Up Study in Orthopaedics. It will verify the long-term safety and performance of the device in the intended patient population, when indicated for the reconstruction of a ligament in the…
- Trial name
- NCT05264389
- Testing
- Poly-Tape Devices
- Where
- 5 sites in United Kingdom
- Volunteers
- 59 people
- Sponsor
- Xiros Ltd
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