Clinical trials: Polymers
Coronary Disease, Drug Eluting Stent
Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease
This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal…
- Conditions
- Coronary Disease, Drug Eluting Stent, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- NCT03287167
- Testing
- 1 month DAPT, 6 months DAPT
- Where
- China
- Volunteers
- 1,720 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Malignant Ascites
A Phase I Study of SIM0388 in Participants With Malignant Ascites.
Malignant Ascites is a common complication of malignant tumor. The objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with Docetaxel Polymeric Micelles…
- Trial name
- SIM0388-101 (NCT07007988)
- Testing
- SIM0388
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Schizophrenia
PK, Safety, and Tolerability Study of RBP-7000 of Different Molecular Weight Polymer in Subjects With Schizophrenia
Primary Objective: To assess the relative bioavailability of RBP-7000 formulated with 2 different molecular weights (MW) (low and high MW as test treatments) of poly (DL-lactide-co-glycolide) with a carboxylic acid end group…
- Trial name
- NCT02687984
- Testing
- RBP-7000
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- Indivior Inc.
Hypertrophic
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a…
- Trial name
- REFINE (NCT01399099)
- Testing
- embrace device
- Where
- 13 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neodyne Biosciences, Inc.
Aortic Dissection
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
- Trial name
- FLAGSHIP_CHL (NCT07387250)
- Testing
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
Coronary Artery Disease
S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.
- Trial name
- NCT03443999
- Testing
- Supraflex Family Sirolimus-eluting Coronary Stent System
- Where
- 7 sites in Netherlands
- Volunteers
- 10,000 people
- Sponsor
- Sahajanand Medical Technologies Limited
Metastatic Breast Cancer (MBC)
Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous…
- Trial name
- NCT06143553
- Testing
- Paclitaxel Polymeric Micelles for Injection, Eribulin Mesilate injection, Capecitabine Tablets
- Where
- 3 sites in China
- Volunteers
- 168 people
- Sponsor
- Shanghai Yizhong Pharmaceutical Co., Ltd.
Coronary Artery Disease
Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES
Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue.
- Trial name
- DISCOVERY123 (NCT01844843)
- Testing
- TCD-10023 drug eluting stent
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Terumo Europe N.V.
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
Pulmonary Emphysema
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.
- Trial name
- ASPIRE (NCT01449292)
- Testing
- Treatment plus Optimal Medical Therapy, Optimal Medical Therapy
- Where
- 40 sites in United States, France and 5 more
- Volunteers
- 300 people
- Sponsor
- Aeris Therapeutics
Cardiovascular Diseases
A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting…
- Trial name
- NCT06412250
- Where
- 32 sites in India, Italy and 2 more
- Volunteers
- 2,000 people
- Sponsor
- Translumina Therapeutics Pvt Ltd.
Non Small Cell Lung Cancer
A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.
- Trial name
- NCT01023347
- Testing
- Paclitaxel (Genexol®), Paclitaxel loaded polymeric micelle (Genexol-PM®)
- Where
- South Korea
- Volunteers
- 276 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
Coronary Artery Disease
Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial
The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.
- Trial name
- NCT01196819
- Testing
- Firehawk, Xience V
- Where
- China
- Volunteers
- 458 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Metastatic Breast Cancer, Stage IV Breast Cancer
BP-C1 in Short-term Treatment of Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether BP-C1 is effective in the treatment of metastatic breast cancer patients who had previously received at least three lines of chemotherapy.
- Trial name
- NCT02783794
- Testing
- BP-C1
- Where
- 6 sites in Russia, Thailand
- Volunteers
- 36 people
- Sponsor
- Meabco A/S
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
AMI
Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent
The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the…
- Trial name
- CREATE (NCT00331578)
- Testing
- Excel drug-eluting coronary artery stent
- Volunteers
- 2,077 people
- Sponsor
- JW Medical Systems Ltd
Coronary Artery Disease
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
- Trial name
- DESSOLVE-I (NCT01247428)
- Testing
- MiStent SES
- Where
- 5 sites in Australia, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- Micell Technologies
Amputation, Prosthesis User
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
- Trial name
- NCT05190354
- Testing
- Xtremity Polymer Prosthetic Socket
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Medical Creations, Inc.
Aortic Valve Stenosis, Aortic Valve Disease
Clinical Trial Evaluating the Safety and Efficacy of Artificial Polymer Heart Valve for the Treatment of Aortic Valve Disease
The purpose of this study is to conduct the clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle，to collect evidence on the device's safety and performance.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Disease, Aortic Valve Regurgitation
- Trial name
- NCT06737757
- Testing
- Artificial polymer heart valves, Bovine pericardial aortic valve
- Volunteers
- 198 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Coronary Artery Disease, Coronary Artery Stenosis
To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System
The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Percutaneous Coronary Intervention, de Novo Lesions in Native Coronary Arteries
- Trial name
- PACIFIER (NCT07098195)
- Testing
- Coronary Stent
- Volunteers
- 2,000 people
- Sponsor
- Poly Medicure Limited