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.
Respiration, Artificial, Acute Hypoxemic Respiratory Failure
Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure
The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute…
- Conditions
- Respiration, Artificial, Acute Hypoxemic Respiratory Failure, Respiratory Insufficiency
- Trial name
- SPIRAL (NCT06042036)
- Testing
- Spontaneous mode of mechanical ventilation
- Where
- 10 sites in Argentina, Bolivia and 8 more
- Volunteers
- 431 people
- Sponsor
- University of Sao Paulo General Hospital
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
Microbiota
Effect of Consuming a Mango and Chia-based Beverage on Modulating the Intestinal Microbiota in Obese Children
This randomized clinical trial evaluates the effect of a mango and chia-based beverage on gut microbiota modulation in 100 Paraguayan children aged 8-16 years with obesity.
- Trial name
- NCT07529119
- Testing
- Mango juice, Mango and chia juice
- Where
- Paraguay
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Universidad Nacional de Caaguazu
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
Hemostasis, Wound Closure
Effective Hemostasis: An Analysis of Hemostatic Sponges Used in Extraction Procedures
Tooth extraction is a common dental procedure, where hemostasis is crucial for patient recovery. This study evaluates the effectiveness of hemostatic sponges in controlling bleeding and promoting postoperative healing.
- Conditions
- Hemostasis, Wound Closure, Pain, Extraction Socket Healing
- Trial name
- NCT07529106
- Testing
- Hemostatic sponge post tooth extraction
- Where
- Paraguay
- Volunteers
- 30 people
- 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
Shock, Thermal Burn
VItamin C in Thermal injuRY: The VICToRY Trial
This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery.
- Trial name
- VICToRY (NCT04138394)
- Testing
- Ascorbic Acid
- Where
- 33 sites in United States, Belgium and 7 more
- Volunteers
- 666 people
- Sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
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
Type 2 Diabetes Mellitus (T2DM), Vitamin D Deficiency
Effect of Vitamin D Supplementation on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency
The goal of this clinical study is to learn whether vitamin D supplementation improves metabolic control in adults with type 2 diabetes mellitus who have vitamin D deficiency.
- Trial name
- VITD-DM2 (NCT07468721)
- Testing
- cholecalciferol (vitamin D3)
- Where
- Paraguay
- Volunteers
- 119 people
- Sponsor
- Faculty of Medical Sciences, Clinical Hospital
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.