Clinical trials: Scaffolding
Plastic Surgery, Reconstructive Surgery
STARS-R Registry: Retrospective Analysis of Poly-4-hydroxybutyrate (P4HB) Scaffold Use
This is a retrospective chart review performed at multiple clinics aimed at providing real-world evidence of the use and safety of the P4HB scaffold.
- Trial name
- NCT04195854
- Testing
- P4HB product
- Where
- 10 sites in United States
- Volunteers
- 1,183 people
- Sponsor
- C. R. Bard
Diabetic Foot Ulcer (DFU)
Evaluating the Efficacy of FoundationDRS Solo in Addition to Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT07290673
- Testing
- FoundationDRS Solo, Standard of Care
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Samaritan Biologics
Critical Limb Ischemia
MOTIV BTK Randomized Controlled Trial
Pre-market clinical evaluation of the MOTIV Sirolimus-Eluting Bioresorbable Scaffold for the planned treatment of infrapopliteal lesions.
- Trial name
- NCT05406622
- Testing
- MOTIV Sirolimus-Eluting Bioresorbable Scaffold, Percutaneous Transluminal Angioplasty (PTA) Device
- Where
- 26 sites in United States, Germany
- Volunteers
- 292 people
- Sponsor
- REVA Medical, Inc.
Radical Prostatectomy, Stress Urinary Incontinence (SUI)
Pivotal Study of Voro Urologic Scaffold
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.
- Trial name
- ARID II (NCT06873581)
- Testing
- Voro Urologic Scaffold
- Where
- 19 sites in United States
- Volunteers
- 266 people
- Sponsor
- Levee Medical, Inc.
Stress Urinary Incontinence, Radical Prostatectomy
Feasibility Study of A VoRo UrologIc ScaffolD (ARID)
The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.
- Trial name
- ARID (NCT06275945)
- Testing
- Voro Urologic Scaffold
- Where
- Panama
- Volunteers
- 40 people
- Sponsor
- Levee Medical, Inc.
Coronary Artery Disease, Coronary Restenosis
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs.
- Trial name
- AbsorbISR (NCT02474485)
- Testing
- BVS Absorb implantation., DEB Sequent Please inflation., Control coronary angiography.
- Where
- Switzerland
- Volunteers
- 53 people
- Sponsor
- SIS Medical AG
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.
Coronary Artery Disease
A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
This study is a prospective, multi-center single arm registry trial, planning to enroll 785 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year after index procedure.
- Trial name
- NCT04179045
- Testing
- The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
- Where
- 5 sites in China
- Volunteers
- 785 people
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
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
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, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS)…
- Trial name
- MeRes-1Extend (NCT02663323)
- Testing
- MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- 4 sites in Brazil, Indonesia and 2 more
- Volunteers
- 64 people
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Coronary Disease, Coronary Artery Disease
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB UK (NCT01977534)
- Testing
- Absorb BVS
- Where
- 24 sites in United Kingdom
- Volunteers
- 1,005 people
- Sponsor
- Abbott Medical Devices
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
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
Peripheral Arterial Disease, Peripheral Vascular Diseases
Natural Vascular Scaffold (NVS) Therapy
The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral
- Trial name
- NCT03148808
- Testing
- NVS Therapy
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Alucent Biomedical
Meniscus Lesion, Meniscus Tear
Long-term Follow-up of Actifit® Meniscal Scaffold Patients.
This study will collect retrospective patient data of Actifit patients (medial and lateral, isolated cases as well as cases with concomitant procedures), including pre-op and any post-op imaging, for 120 retrospective Actifit…
- Trial name
- NCT07800923
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Orteq Sports Medicine
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, 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