Clinical trials: Scaffolding
Urethral Stricture
Bioengineered Collagen Implant for Urethral Stricture Repair
The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral…
- Trial name
- NCT05463991
- Testing
- Bioengineered collagen implant
- Where
- Malaysia
- Volunteers
- 5 people
- Sponsor
- Regenosca SA
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Coronary Artery Disease
Resorbable Magnesium Scaffolds Registry
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without…
- Trial name
- NCT04679740
- Testing
- Magmaris, Freesolve
- Where
- 13 sites in Australia, Germany and 5 more
- Volunteers
- 1,106 people
- Sponsor
- Biotronik AG
Atherosclerosis, Peripheral Artery Disease
The ABSORB BTK (Below The Knee) Clinical Investigation
The purpose of the ABSORB BTK Clinical Investigation is to evaluate the safety and efficacy of the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS) in subjects with critical limb ischemia (CLI) following…
- Conditions
- Atherosclerosis, Peripheral Artery Disease, Peripheral Vascular Disease, PAD
- Trial name
- NCT01341340
- Testing
- Everolimus Eluting BVS
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Breast Reconstruction
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Non-melanoma Skin Cancer, Basal Cell Carcinoma
EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds
The purpose of study is to assess the safety and performance of EktoTherix™ Tissue Repair Scaffold in the treatment of full-thickness, dermatologic wounds created by the surgical removal of non-melanoma skin cancers.
- Conditions
- Non-melanoma Skin Cancer, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Trial name
- NCT02409628
- Testing
- EktoTherix
- Where
- 3 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Neotherix Limited
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
Carotid Artery Disease, Carotid Artery Stenosis
The Gore SCAFFOLD Clinical Study
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
- Trial name
- NCT01901874
- Testing
- Carotid Artery Stenting
- Where
- 2 sites in United States
- Volunteers
- 312 people
- Sponsor
- W.L.Gore & Associates
Atherosclerosis, Peripheral Vascular Disease
ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common…
- Conditions
- Atherosclerosis, Peripheral Vascular Disease, Claudication
- Trial name
- NCT01468974
- Testing
- ESPRIT BVS
- Where
- 8 sites in Austria, Belgium and 2 more
- Volunteers
- 35 people
- Sponsor
- Abbott Medical Devices
Foot Ulcer, Diabetic
Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix
The objective of this study is to compare the effectiveness of PriMatrix Moist Wound Therapy (MWT) with Standard of Care MWT for the treatment of chronic diabetic foot ulcers in subjects with diabetes mellitus and without…
- Trial name
- HEALED (NCT01729286)
- Testing
- PriMatrix Moist Wound Therapy, Standard of Care Moist Wound Therapy
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 92 people
- Sponsor
- Integra LifeSciences Corporation
Infrapopliteal Lesions, Critical Limb Ischemia
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with…
- Trial name
- NCT05971394
- Testing
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Coronary Artery Disease
A First-in-Man Study of the Firesorb BVS (FUTURE-I)
This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time.
- Trial name
- FUTURE-I (NCT02659254)
- Testing
- Sirolimus Target Eluting Bioresorbable Vascular Scaffold
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Coronary Artery Disease, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)
The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- RENASCENT III (NCT02900937)
- Testing
- AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 13 sites in Colombia, Italy
- Volunteers
- 70 people
- Sponsor
- Amaranth Medical Inc.
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System
The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-II (NCT05540223)
- Testing
- Freesolve RMS, Xience DES
- Where
- Germany
- Volunteers
- 1,861 people
- Sponsor
- Biotronik AG
Knee Injuries
Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament
The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.
- Trial name
- NCT02540811
- Testing
- dCELL® ACL Scaffold
- Where
- 8 sites in Poland, Spain and 1 more
- Volunteers
- 40 people
- Sponsor
- Tissue Regenix Ltd
Iliac Artery Stenosis, Iliac Artery Occlusion
A First-in-Man Clinical Trial to Evaluate the Safety and Feasibility of ICS-Elpis in Patients With Iliac Artery Stenosis or Occlusion Lesions
This trial is a prospective, single-center, first-in-man clinical trial to evaluate the feasibility, preliminary safety and effectiveness of the Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System.
- Trial name
- NCT07290101
- Testing
- Bioresorbable Peripheral Balloon-Expandable Covered Scaffold System
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
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
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
Coronary Artery Disease, Coronary Artery Stenosis
Absorb IV Randomized Controlled Trial
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02173379
- Testing
- Absorb BVS, XIENCE
- Where
- 120 sites in United States, Australia and 3 more
- Volunteers
- 2,604 people
- Sponsor
- Abbott Medical Devices