Clinical trials: Reconstruction
Tumor, Facial Fracture
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.
This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.
- Conditions
- Tumor, Facial Fracture, Mandibular Fractures, Fibrous Dysplasia
- Trial name
- NCT04931056
- Testing
- Titanium Facial Plates, Titanium Mandibular Plates, Add-on Condyle
- Where
- Argentina
- Volunteers
- 91 people
- Sponsor
- Zimmer Biomet
Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair
GLYCAR Post Market Multicenter Study
Prospective, non-interventional, observational, multi-center, single arm, post market clinical follow-up study
- Conditions
- Congenital Premature Cardiac Closure, Cardiac and Great Vessel Reconstruction and Repair, Peripheral Vascular Reconstruction and Repair
- Trial name
- CIP002 (NCT05661981)
- Testing
- GLYCAR Pericardial Patch
- Where
- 4 sites in France, Germany
- Volunteers
- 110 people
- Sponsor
- GLYCAR SA (Pty) Ltd
Breast Reconstruction
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
- Trial name
- NCT06575192
- Testing
- ARTIA Reconstructive Tissue Matrix
- Where
- 23 sites in United States
- Volunteers
- 264 people
- Sponsor
- AbbVie
Acquired Bleeding Disorder, Trauma
Activated Recombinant Human Factor VII in Pelvic-acetabular Fracture Reconstruction
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy of activated recombinant human factor VIIgiven in conjunction with standard therapy in patients undergoing major orthopaedic surgery following…
- Trial name
- NCT01601457
- Testing
- activated recombinant human factor VII
- Where
- United Kingdom
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Mandible Fracture, Mandibular Reconstruction
Stryker's Surgeon iD Mandible Reconstruction Plates: A Retrospective Post Market Follow Up
A retrospective post market follow up to confirm safety and performance of Stryker's Surgeon iD Plates (SMRP) medical device. The study is performed to confirm the product's performance and safety by systematically collecting…
- Trial name
- SMRP (NCT07221916)
- Testing
- Mandibular Reconstruction
- Where
- 2 sites in United States, Germany
- Volunteers
- 70 people
- Sponsor
- Stryker Craniomaxillofacial
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.
Mandibular Diseases, SSM
Virtual Anatomical Reconstruction of Mandibular Bone Defects Using a Statistical Shape Model
Hundred already taken CT-scans (50 male and 50 female) will be anonymized. These scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the…
- Trial name
- NCT04475237
- Testing
- CT-scan evaluation and segmentation
- Where
- Belgium
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CADskills
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 Reconstruction After Mastectomy
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well…
- Trial name
- PRO-BRA (NCT01885572)
- Testing
- TiLOOP Bra
- Where
- 8 sites in Germany
- Volunteers
- 267 people
- Sponsor
- Pfm Medical Mepro Gmbh
ACL Reconstruction
Efficacy and Tolerability of a Nutritional Supplement, Plactive Progen, in ACL Reconstruction
This was a prospective, multicenter, randomized, open-label, phase IV trial to compare the efficacy of supplementation with plasma proteins, hydrolyzed collagen (CH), a complex of HA-CS (HC-15), and vitamin C combined with a…
- Trial name
- NCT03355651
- Testing
- PROGEN
- Volunteers
- 80 people
- Sponsor
- OPKO Health, Inc.
Intracranial Aneurysms
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
To date the standard non-surgical treatment strategy for treating un-ruptured intracranial aneurysms is the use of either coils or self-expandable stents.
- Trial name
- NCT01084681
- Testing
- Endovascular treatment of intracranial aneurysms, Endovascular treatment of intracranial aneurysm with coils
- Where
- Germany
- Volunteers
- 160 people
- Sponsor
- Balt International
Microtia
AuriNovo for Auricular Reconstruction
AuriNovo provides a patient-specific, biological construct for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV.
- Trial name
- NCT04399239
- Testing
- AuriNovo
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- 3DBio Therapeutics
Anterior Cruciate Ligament Reconstruction
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.
- Trial name
- NCT00775892
- Testing
- SeriACL Device ACL Reconstruction
- Where
- 6 sites in Austria, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- Serica Technologies, Inc.
Anterior Cruciate Ligament Injury, Osteoarthritis
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction
- Trial name
- NCT01088191
- Testing
- MSB-CAR001 Combined With Hyaluronan, Hyaluronan
- Where
- Australia
- Volunteers
- 17 people
- Sponsor
- Mesoblast, Ltd.
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
Cartilage Disease
Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with full thickness cartilage defects in the hip.
- Trial name
- HIP-ACTION (NCT02179346)
- Where
- 3 sites in Germany
- Volunteers
- 21 people
- Sponsor
- Tetec AG
Tibia Fracture Non Union Bone
Study to Analyze the Effects of EBI OsteoGen™ on the Surgical Reconstruction of Tibia Non-unions
The purpose of this clinical outcomes collection study is to analyze the effect of the EBI OsteoGen™ Direct Current Stimulator upon surgical reconstruction of tibia nonunion (no visible progressive signs of healing) fracture in a…
- Trial name
- NCT00726193
- Testing
- OsteoGen
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Zimmer Biomet
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
Guo's Visceral Arteries Reconstruction: First in Man Study
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
- Trial name
- NCT04731636
- Testing
- Thoracoabdominal aortic stent system
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Juxta Renal Abdominal Aortic Aneurysm Without Rupture
Guo's Visceral Arteries Reconstruction :The First in Man Study of WeFlow-JAAA Stent Graft System
This study is the First in Man Study of WeFlow-JAAA Stent Graft System manufactured by EndoNom Medtech(Hangzhou) Co., Ltd.
- Trial name
- NCT04745546
- Testing
- WeFlow-JAAA Stent Graft System
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Perfusion; Complications
Evaluation of Tissue Oxygen Levels During Breast Reconstruction With a New Surgical Device
This study is designed to evaluate the information provided to the clinicians by the surgical imaging device. It is also to gain insight on the user interface and how "user friendly" it is to the clinician.
- Trial name
- Presygen™ (NCT03715270)
- Testing
- Image surgical area
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Christie Medical Holdings, Inc.