Clinical trials: Scaffolding
Pulmonary Artery Stenosis
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.
- Trial name
- IRIS (NCT04973540)
- Testing
- Iron Bioresorbable Scaffold System (IBS Angel)
- Where
- 10 sites in China
- Volunteers
- 82 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle
BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
The purpose of this trial is to evaluate the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) compared to marrow stimulation in the treatment of chondral and osteochondral lesions located on the medial…
- Conditions
- Chondral or Osteochondral Lesion of Medial Femoral Condyle, Chondral or Osteochondral Lesion of Lateral Femoral Condyle, Chondral or Osteochondral Lesion of Trochlea
- Trial name
- NCT01477008
- Testing
- BiPhasic Cartilage Repair Implant, Marrow Stimulation
- Where
- 11 sites in Taiwan
- Volunteers
- 92 people
- Sponsor
- BioGend Therapeutics Co.Ltd
Pectus Excavatum
Pectus Excavatum Camouflage (IT)
The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT).
- Trial name
- NCT05634070
- Testing
- PCL Pectus scaffold implantation and autologous fat grafting
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- BellaSeno GmbH
Peripheral Arterial Disease, Vascular Diseases
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
- Conditions
- Peripheral Arterial Disease, Vascular Diseases, Stenosis, Femoropopliteal Stenosis
- Trial name
- Efemoral I (NCT04584632)
- Testing
- Efemoral Vascular Scaffold System (EVSS)
- Where
- 8 sites in Australia, New Zealand
- Volunteers
- 100 people
- Sponsor
- Efemoral Medical, Inc.
Injury, Spinal Cord
Study of Probable Benefit of the Neuro-Spinal Scaffold™ in Subjects With Complete Thoracic AIS A Spinal Cord Injury as Compared to Standard of Care
This is a randomized, controlled, single-blind, multicenter, two Arm (Treatment or "Scaffold" Arm; Standard of Care or "Comparator" Arm) of a Neuro-Spinal Scaffold to evaluate whether the Scaffold is safe and demonstrates…
- Trial name
- INSPIRE 2 (NCT03762655)
- Testing
- Neuro-Spinal Scaffold
- Where
- 16 sites in United States
- Volunteers
- 20 people
- Sponsor
- InVivo Therapeutics
Traumatic Cervical Acute Spinal Cord Injury
Pilot Study of the Neuro-Spinal Scaffold for the Treatment of AIS A Cervical Acute SCI
Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels The purpose of this study is to support an…
- Trial name
- NCT03105882
- Testing
- Neuro-Spinal Scaffold
- Where
- Canada
- Sponsor
- InVivo Therapeutics
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
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
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