Clinical trials: Scaffolding
Breast Reconstruction
The SERI® Surgical Scaffold Use in Reconstruction Post Market Study for Tissue Support and Repair in Breast Reconstruction Surgery
The purpose of the study is to obtain clinical experience with the use of SERI® Surgical Scaffold for tissue support and repair in breast reconstruction.
- Trial name
- NCT01256502
- Testing
- SERI® Surgical Scaffold
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Sofregen Medical, Inc.
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
Periapical Periodontitis
Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional…
- Trial name
- RanoKure (NCT03102879)
- Testing
- Regenerative Endodontic Procedure, Conventional Root Canal Treatment
- Where
- Chile
- Volunteers
- 36 people
- Sponsor
- Universidad de los Andes, Chile
Coronary Artery Disease
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 people
- Sponsor
- Abbott Medical Devices
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
Subjects Requiring Revision Breast Augmentation Surgery
SERI® Surgical Scaffold for Soft Tissue Support in Revision Augmentation Surgery
An evaluation of the clinical performance of SERI® Surgical Scaffold for soft tissue support in subjects undergoing revision augmentation surgery for increased nipple to inframammary fold distance.
- Trial name
- NCT02030938
- Testing
- SERI® Surgical Scaffold
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Sofregen Medical, Inc.
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 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
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
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
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
Meniscus Tear, Knee Meniscus Injury
High-Purity Type I Collagen Augmentation in Meniscal Repair
This prospective, single-arm feasibility study evaluates the safety, procedural feasibility, and early clinical outcomes of High-Purity Type I Collagen used as an adjunct in arthroscopic meniscal repair.
- Conditions
- Meniscus Tear, Knee Meniscus Injury, Meniscal Repair, Knee Arthroscopy (for Diagnostic or Therapy)
- Trial name
- NCT07352410
- Testing
- High-Purity Type I Collagen
- Where
- India
- Volunteers
- 18 people
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
Ventral Hernia Repair
SERI® Surgical Scaffold Postmarket Study of Soft Tissue Support in Ventral Hernia Repair
Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.
- Trial name
- NCT01981044
- Testing
- Silk surgical mesh
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sofregen Medical, Inc.
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
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
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
Myocardial Ischemia, Coronary Artery Stenosis
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- ABSORB EXTEND (NCT01023789)
- Testing
- ABSORB BVS
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 812 people
- Sponsor
- Abbott Medical Devices
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