Clinical trials: active, 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.
Obesity, Diabetes Mellitus, Type 2
Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.
This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population.
- Trial name
- REAL-TIRZEPY (NCT07588438)
- Testing
- Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.)
- Where
- Paraguay
- Volunteers
- 160 people
- Sponsor
- Las Rías Medical Center
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
Lipid Metabolism Disorders
Effect of Ilex Paraguariensis Harvest Time and Consumption Method of Processed Yerba Mate on the Lipid Profile
Introduction: This project studies the impact of Ilex paraguariensis harvest time, commonly known as yerba mate, and its consumption mode (mate, tereré, and mate/terere) on the lipid profile of consumers in the Department of…
- Trial name
- NCT06896175
- Testing
- Yerba mate consumption (Ilex paraguayensis) A, Yerba mate comsuption (ilex paraguayencis) B
- Where
- Paraguay
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- Universidad Nacional de Caaguazu
Tuberculosis (TB), TB Infection
Prevention and Mass Screening of TB in Prisons in Paraguay
The goal of this interventional study is to evaluate three tuberculosis (TB) screening and prevention strategies in prisons in Paraguay.
- Conditions
- Tuberculosis (TB), TB Infection, Prisoners, Epidemiology
- Trial name
- PRESMAP-TB (NCT07520448)
- Testing
- Type 1 - Intensive Intervention, Type 2 - Optimized intervention, Type 3. Control.
- Where
- Paraguay
- Volunteers
- 4,500 people
- Sponsor
- Universidad Nacional de Caaguazu
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
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.
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.
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
Device Related Infection, Device Malfunction
Project My Heart Your Heart: Pacemaker Reuse
Lack of access to pacemakers is a major challenge to the provision of cardiovascular health care in Low and Middle Income Countries (LMIC).
- Conditions
- Device Related Infection, Device Malfunction, Bradycardia
- Trial name
- MHYH (NCT04016870)
- Testing
- Reconditioned Pacemaker, New Pacemaker
- Where
- 8 sites in Kenya, Mexico and 5 more
- Volunteers
- 370 people
- Sponsor
- University of Michigan
Chronic Kidney Diseases, Chronic Kidney Failure
SelfWrap-Assisted Arteriovenous Fistulas
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of VenoStent's SelfWrap® Bioabsorbable Perivascular Wrap on arteriovenous fistulas (AVFs).
- Conditions
- Chronic Kidney Diseases, Chronic Kidney Failure, End Stage Renal Disease, End Stage Kidney Disease
- Trial name
- SW-AVF (NCT05418816)
- Testing
- SelfWrap Bioabsorbable Perivascular Wrap
- Where
- Paraguay
- Volunteers
- 20 people
- Sponsor
- VenoStent
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 1 (NCT06883617)
- Testing
- Neuro stimulator Implant
- Where
- Paraguay
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
Diabetes Mellitus, Type 2, Hypertension
Arterial Ablation for the Treatment of Type 2 Diabetes Mellitus and Its Comorbidities
This study is assess the safety and performance of the Neurotronic Infusion catheter for treatment of patients with Type 2 Diabetes (T2DM) and hypertension.
- Trial name
- NECTAR III (NCT05363761)
- Testing
- Neurotronic Infusion Catheter
- Where
- 3 sites in Panama, Paraguay
- Volunteers
- 50 people
- Sponsor
- Neurotronic, Inc.