Clinical trials: in Paraguay
Peripheral Artery Disease
IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD
To evaluate the safety and performance of the IV-X Medical Intravascular Lithotripsy (IVL) System in adults in order to demonstrate the ability of the IV-X Medical IVL System to safely and effectively deliver IVL treatment…
- Trial name
- HELIX-PAD-FIH (NCT07747883)
- Testing
- IV-X Medical IVL System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- IVX Medical
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- Trial name
- NCT07140562
- Testing
- Tricuspid Annular Therapy System
- Where
- Paraguay
- Volunteers
- 25 people
- Sponsor
- Tangent Cardiovascular Inc.
Kidney Disease, End-Stage
PATH-03 Paraguay Feasibility Study
The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
- Trial name
- NCT07034092
- Testing
- ePATH System will be used to create an endoAVF
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Pathfinder Medical
Degenerative Disc Disease, Chronic Low-back Pain
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
- Trial name
- LOPAIN2 (NCT05508360)
- Testing
- PerQdisc Nucleus Replacement System
- Where
- 11 sites in Colombia, Costa Rica and 3 more
- Volunteers
- 72 people
- Sponsor
- Spinal Stabilization Technologies
Coronary Angioplasty, Bifurcation Coronary Artery Disease
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)
This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.
- Conditions
- Coronary Angioplasty, Bifurcation Coronary Artery Disease, Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- Trial name
- NCT07649798
- Testing
- MD-SBA DES System
- Where
- Paraguay
- Volunteers
- 13 people
- Sponsor
- Advanced Bifurcation Systems Inc.
End Stage Kidney Disease (ESRD)
STARgraft (10401) Pilot
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
- Trial name
- NCT07555717
- Testing
- STARgraft (10401)
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- Healionics Corporation
End Stage Renal Disease
Evaluation of STARgraft-3 for Hemodialysis
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft-3 hemodialysis access graft.
- Trial name
- NCT05729620
- Testing
- Implant of STARgraft-3 shunt in the upper arm and subsequent use for hemodialysis access
- Where
- Paraguay
- Volunteers
- 21 people
- Sponsor
- Healionics Corporation
Obesity, Type 2 Diabetes Mellitus
Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
This is a Phase 4 observational study evaluating the safety and effectiveness of tirzepatide (T.G.) manufactured by INDUFAR S.A.
- Conditions
- Obesity, Type 2 Diabetes Mellitus, Overweight With Comorbidities
- Trial name
- NCT07492563
- Testing
- Tirzepatide (T.G.)
- Where
- Paraguay
- Volunteers
- 300 people
- Sponsor
- LABORATORIOS INDUFAR
Multiple Sclerosis
Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis
This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis…
- Trial name
- MuSicalE (NCT03593590)
- Testing
- Ocrelizumab
- Where
- 158 sites in Austria, Belgium and 23 more
- Volunteers
- 1,710 people
- Sponsor
- Hoffmann-La Roche
Back Pain With Radiation, Radiculopathy
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3
This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure…
- Conditions
- Back Pain With Radiation, Radiculopathy, Back Pain, Disc Herniation
- Trial name
- LOPAIN3 (NCT05732818)
- Testing
- PerQdisc Nucleus Replacement System
- Where
- 2 sites in Paraguay, Uzbekistan
- Volunteers
- 50 people
- Sponsor
- Spinal Stabilization Technologies
End-Stage Renal Disease Requiring Haemodialysis
Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation.
- Trial name
- Amplifi FIH (NCT07058610)
- Testing
- Amplifi Vein Dilation System
- Where
- Paraguay
- Volunteers
- 19 people
- Sponsor
- Amplifi Vascular, Inc.
Chronic Rhinosinusitis
Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)
It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP. Participants will receive AIRIVER Nasal drug-coated balloon treatment.
- Trial name
- NCT05883462
- Testing
- Airiver Nasal Drug Coated Balloon (DCB) Catheter.
- Where
- Paraguay
- Volunteers
- 45 people
- Sponsor
- Airiver Medical, Inc.
Chronic Kidney Diseases
everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients.
- Trial name
- NCT03708562
- Testing
- everlinQ endoAVF System
- Where
- Paraguay
- Volunteers
- 24 people
- Sponsor
- C. R. Bard
Coronary Artery Disease
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing…
- Trial name
- VCAB-1 (NCT06434935)
- Testing
- CABA
- Where
- Paraguay
- Volunteers
- 5 people
- Sponsor
- Vascudyne, Inc.
Ventricular Arrythmia, Ventricular Fibrillation
Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study
The ASCEND EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of the study is to evaluate the Investigational Devices through at least 3-months of…
- Conditions
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- Trial name
- ASCEND EV (NCT06592001)
- Testing
- Atala™ lead
- Where
- 3 sites in Croatia, New Zealand and 1 more
- Volunteers
- 19 people
- Sponsor
- AtaCor Medical, Inc.
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the…
- Trial name
- NCT02119832
- Testing
- Endovasccular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 17 people
- Sponsor
- C. R. Bard
Chronic Kidney Disease (CKD)
A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001
The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.
- Trial name
- NCT02119845
- Testing
- Endovascular AVF (EndoAVF)
- Where
- Paraguay
- Volunteers
- 16 people
- Sponsor
- C. R. Bard
Mitral Regurgitation
Feasibility Study of the Tioga TMVR System
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)
- Trial name
- NCT06038838
- Testing
- Tioga TMVR System
- Where
- 5 sites in Brazil, Georgia and 2 more
- Volunteers
- 30 people
- Sponsor
- Tioga Cardiovascular, Inc.
Obstructive Sleep Apnea
Assessment of OSA in Latin American and Response to Neuromod Therapy
The purpose of this study is to characterize the upper airway of Latin American subjects who have been diagnosed with moderate/severe obstructive sleep apnea (OSA) and assess response to a neuromodulation therapy to treat OSA.
- Trial name
- Trans-Q DISE (NCT06762873)
- Testing
- Drug Induced Sleep Endoscopy with PNS
- Where
- Paraguay
- Volunteers
- 50 people
- Sponsor
- Lunair Medical
Conduction Defect
Subcostal Temporary Extravascular Pacing V Study
The STEP V Study is a prospective, multicenter, acute (in-hospital), single-arm feasibility study. The objective of the study is to evaluate the early safety and performance of the latest AtaCor EV Temporary Pacing Lead System…
- Trial name
- STEP V (NCT05633394)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 29 people
- Sponsor
- AtaCor Medical, Inc.