Clinical trials: Scaffolding
Esophageal Adenocarcinoma
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
The purpose of this study is to see if implanting MatriStem will lower the risk of one of the more common complications after stomach or esophagus surgery.
- Trial name
- NCT01970306
- Testing
- MatriStem PSM
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Mastopexy
Circumferential Periareolar Mastopexy Using SERI Surgical Scaffold
The purpose of this study is to evaluate the clinical performance of SERI® Surgical Scaffold to maintain the size of the areola by providing additional soft tissue support after circumferential periareolar mastopexy.
- Trial name
- NCT02293798
- Testing
- silk surgical scaffold
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Mark Mofid MD
Knee Injuries
Trial Comparing BST-CarGel and Microfracture in Repair of Articular Cartilage Lesions in the Knee
This study will investigate whether the treatment of damaged cartilage in the knee with BST-CarGel will increase the amount and quality of cartilage repair tissue when compared with microfracture alone.
- Trial name
- NCT00314236
- Testing
- BST-CarGel with Microfracture, Microfracture without BST-CarGel
- Where
- 18 sites in Canada, South Korea and 1 more
- Volunteers
- 80 people
- Sponsor
- Piramal Healthcare Canada Ltd
Coronary Artery Disease
NeoVas Bioresorbable Coronary Scaffold First-in-Man Study
The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas…
- Trial name
- NCT02195414
- Testing
- NeoVas BCS
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Coronary Artery Disease, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02229864
- Testing
- Coronary artery stenting: Absorb BVS
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
LIFE-BTK PK Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside…
- Trial name
- NCT05208905
- Testing
- Esprit BTK Device
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Diabetic Foot Ulcer
PriMatrix for the Management of Diabetic Foot Ulcers
The study will evaluate the efficacy of PriMatrix Dermal Repair Scaffold in the management of diabetic foot ulcers in subjects with diabetes mellitus versus the Standard of Care treatment.
- Trial name
- NCT03010319
- Testing
- PriMatrix Dermal Repair Scaffold, Secondary Dressings, Offloading device
- Where
- 17 sites in United States
- Volunteers
- 226 people
- Sponsor
- Integra LifeSciences Corporation
Rotator Cuff Tear
LifeNet: Extracellular Matrix Graft in Rotator Cuff Repair
This trial is to evaluate the effectiveness of the ArthroFLEX® ECM scaffold graph as an augment in rotator cuff repair surgery to reduce the failure rate of rotator cuff repairs for large and massive rotator cuff tears.
- Trial name
- NCT03551509
- Testing
- ArthroFLEX ECM scaffold graft, Control, Alternative Treatment Group
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Gregory Gilot
Late Complication From Skin Graft, Infection of Skin Donor Site
Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment
1. Silk sericin wound dressing may reduce time for complete epithelialisation of split-thickness skin graft donor sites compared to Bactigras®. 2.
- Conditions
- Late Complication From Skin Graft, Infection of Skin Donor Site, Impaired Wound Healing, Pain, Intractable
- Trial name
- NCT01539980
- Testing
- Sericin scaffold
- Where
- Thailand
- Volunteers
- 30 people
- Sponsor
- Chulalongkorn University
Coronary Artery Disease
Elixir Medical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - Cx Registry
This additional arm of the DESolve Nx study is an evaluation of the CE Mark approved DESolve Cx Novolimus Eluting Bioresorbable Scaffold System.
- Trial name
- NCT04034121
- Testing
- DESolve Cx drug eluting coronary scaffold system
- Where
- 3 sites in Belgium, Brazil
- Volunteers
- 50 people
- Sponsor
- Elixir Medical Corporation
Wound Heal
Safety of Microporous Annealed Particle (MAP) Wound Matrix in Patients With Clean Surgical Wounds.
A randomized, open-label, investigational safety evaluation of the Microporous Annealed Particle (MAP) Wound Matrix (TT101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with Mohs…
- Trial name
- MOSAIC (NCT06600152)
- Testing
- MAP Wound Matrix, DuoDerm
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tempo Therapeutics
Full Thickness Rotator Cuff Tear
BioFiber Scaffold Post-Market Observational Study
The aim of this study is to collect and report data from a consecutive series of patients implanted with these products as part of a post-market surveillance plan for CE Mark approval in the European Union.
- Trial name
- NCT01849458
- Testing
- BioFiber
- Where
- 3 sites in United States, France
- Volunteers
- 50 people
- Sponsor
- Stryker Trauma and Extremities
Ischemic Heart Disease, Angina Pectoris
Absorb GT1 Japan PMS
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for…
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT03409731
- Testing
- ABSORB GT1 BVS
- Where
- 15 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
LIFE-BTK Randomized Controlled Trial
The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed…
- Trial name
- LIFE-BTK (NCT04227899)
- Testing
- Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 50 sites in United States, Australia and 4 more
- Volunteers
- 261 people
- Sponsor
- Abbott Medical Devices
Barretts Esophagus With High Grade Dysplasia, Barrett Adenocarcinoma
Endoscopic Mucosal Resection and Cellular Matrix
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.
- Trial name
- NCT03240679
- Testing
- Acell MatriStem® Surgical Matrix
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Mayo Clinic
Inguinal Hernia
Neo-nervegenesis in Inguinal Hernia Implant ProFlor
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
- Trial name
- NCT04171102
- Testing
- ProFlor Hernia implant
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Cagliari
Traumatic Thoracic Acute Spinal Cord Injury
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with…
- Trial name
- NCT02138110
- Testing
- Neuro-Spinal Scaffold
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- InVivo Therapeutics
Chronic Total Occlusion of Coronary Artery, Coronary Occlusion
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to: Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01759290
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- Belgium
- Volunteers
- 1,800 people
- Sponsor
- Abbott Medical Devices