Clinical trials: in Paraguay
Conduction Defect
Subcostal Temporary Extravascular Pacing IV (STEP IV) Study
The STEP IV Study is a prospective, single-center, non-randomized, single-arm study without concurrent or historical controls. The objective of the study is to generate safety and performance data of the latest AtaCor EV…
- Trial name
- STEP IV (NCT05457673)
- Testing
- AtaCor StealthTrac Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Ventricular Arrythmia
Non-vascular ICD Electrode Configuration Feasibility Study
This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.
- Trial name
- NCT04809701
- Testing
- Temporary implantation of defibrillation coils and pulse generator, Defibrillation following induction of VA (Configuration A first), Defibrillation following induction of VA (Configuration B first)
- Where
- 3 sites in Chile, Czechia and 1 more
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Covid19 Vaccine
A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults
The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.
- Trial name
- NCT05011526
- Testing
- MVC-COV1901, AZD1222
- Where
- 2 sites in Paraguay
- Volunteers
- 1,030 people, healthy volunteers welcome
- Sponsor
- Medigen Vaccine Biologics Corp.
Biliary Stricture, Biliary Anastomotic Stenosis
DIGEST I Drug Coated Balloon for Biliary Stricture
DIGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
- Conditions
- Biliary Stricture, Biliary Anastomotic Stenosis, Biliary Obstruction, Biliary Disease
- Trial name
- DIGEST (NCT03997994)
- Testing
- GIE Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 8 people
- Sponsor
- GIE Medical
Intestinal Stricture
POISE I Pilot Study
POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.
- Trial name
- POISE (NCT03886324)
- Testing
- GIE Medical Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- GIE Medical
Esophageal Stricture
INGEST I Pilot Study
INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.
- Trial name
- INGEST (NCT03885310)
- Testing
- GIE Drug Coated Balloon
- Where
- Paraguay
- Volunteers
- 9 people
- Sponsor
- GIE Medical
Ventricular Arrhythmia, Ventricular Tachycardia
Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study
The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely…
- Conditions
- Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation
- Trial name
- PASS PULL (NCT05099289)
- Testing
- AtaCor EV-ICD Lead
- Where
- Paraguay
- Volunteers
- 18 people
- Sponsor
- AtaCor Medical, Inc.
Conduction Defect
AtaCor Subcostal Temporary Extravascular Pacing III Study
Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System.
- Trial name
- STEP III (NCT04538287)
- Testing
- AtaCor StealthTrac Lead
- Where
- 4 sites in Czechia, New Zealand and 1 more
- Volunteers
- 33 people
- Sponsor
- AtaCor Medical, Inc.
High Risk Percutaneous Coronary Intervention
HeartMate PHP™ CE Mark Clinical Investigation Plan
The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable…
- Trial name
- HM PHP CE Mark (NCT02156609)
- Testing
- Percutaneous ventricular support with the HeartMate PHP
- Where
- 7 sites in Colombia, Netherlands and 2 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
End Stage Renal Disease
Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access (TRUE HD I Study)
Prospective, nonrandomized, single-arm, single-center, open-label, first-in-human clinical study in subjects with end-stage renal disease (ESRD) and not candidates for an autogenous fistula creation.
- Trial name
- NCT04905511
- Testing
- natural human collagen arteriovenous graft for hemodialysis access
- Where
- Paraguay
- Volunteers
- 10 people
- Sponsor
- Vascudyne, Inc.
Gaucher Disease, Type 1
A Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to this deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular…
- Trial name
- NCT00430625
- Testing
- VPRIV ®,
- Where
- 5 sites in Argentina, Israel and 3 more
- Volunteers
- 25 people
- Sponsor
- Shire
Conduction Defect
Subcostal Temporary Extracardiac Pacing II Study
Up to 12 subjects will be enrolled (up to 8 undergoing an AtaCor Temporary Pacing System procedure) in order to evaluate initial safety and performance of the AtaCor Temporary Pacing System when used with three (3) strategies for…
- Trial name
- STEP II (NCT04374929)
- Testing
- StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy, StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid, Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)
- Where
- 2 sites in New Zealand, Paraguay
- Volunteers
- 7 people
- Sponsor
- AtaCor Medical, Inc.
Gaucher Disease, Type 1
An Open-Label Extension Study of GA-GCB ERT in Patients With Type 1 Gaucher Disease
The purpose of this study is to evaluate the long-term safety of every other week dosing of Gene-Activated® human glucocerebrosidase (GA-GCB, velaglucerase alfa) intravenously in patients with type 1 Gaucher disease.
- Trial name
- NCT00635427
- Testing
- VPRIV®
- Where
- 21 sites in United States, Argentina and 9 more
- Volunteers
- 95 people
- Sponsor
- Shire
Fabry Disease
Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.
- Trial name
- NCT00864851
- Testing
- Replagal
- Where
- 12 sites in United States, Australia and 6 more
- Volunteers
- 44 people
- Sponsor
- Shire
Gaucher Disease, Type 1
Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside accumulates within macrophages leading to cellular…
- Trial name
- NCT00553631
- Testing
- velaglucerase alfa, imiglucerase
- Where
- 11 sites in United States, Argentina and 7 more
- Volunteers
- 34 people
- Sponsor
- Shire
Critical Limb Ischemia, Peripheral Artery Disease
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the…
- Trial name
- NCT02044003
- Testing
- Innovasc Tack Intravascular Staple System (Tack)
- Where
- 2 sites in Paraguay
- Volunteers
- 11 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Conduction Defect
Subcostal Temporary Extracardiac Pacing Study
Up to 15 subjects will be enrolled to evaluate initial safety and performance of the AtaCor Temporary Pacing System. Safety will be evaluated through analysis of all Adverse Events.
- Trial name
- STEP (NCT04096365)
- Testing
- Subcostal Temporary Extracardiac Pacing Lead
- Where
- Paraguay
- Volunteers
- 12 people
- Sponsor
- AtaCor Medical, Inc.
Diffuse Large B-cell Lymphoma
Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma
This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®)…
- Trial name
- NCT02268045
- Testing
- RTXM83, Mabthera
- Where
- 87 sites in Argentina, Brazil and 10 more
- Volunteers
- 272 people
- Sponsor
- mAbxience Research S.L.
Gaucher Disease
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60…
- Trial name
- NCT01132690
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 11 people
- Sponsor
- Pfizer
Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols…
- Trial name
- NCT01411228
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 15 people
- Sponsor
- Pfizer