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NCT ID: NCT03916731 Recruiting - Clinical trials for End Stage Renal Disease

Evaluation of STARgraft AV for Hemodialysis Access

Start date: April 2, 2019
Phase: N/A
Study type: Interventional

This study is a First-in-Human, single site, prospective, randomized, controlled evaluation of the safety and effectiveness of the Healionics STARgraft AV hemodialysis access graft. The STARgraft has been demonstrated in preclinical studies to have improved resistance to the common failure mode of venous anastomosis stenosis. Performance of the STARgraft AV will be compared against control implants of commercially available standard ePTFE grafts approved for the same use. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to: 1. Demonstrate improved primary patency of the investigational STARgraft AV compared to the ePTFE controls over a period of 6 months, with extended results to 1 year. 2. Verify safety of the STARgraft AV multilayer construction in extended vascular access use. It is intended to enroll 25 subjects each for the investigational devices and the controls respectively (50 total) with randomized device allocation at subject presentation for implant surgery.

NCT ID: NCT03886324 Recruiting - Clinical trials for Intestinal Stricture

POISE I Pilot Study

POISE
Start date: February 25, 2019
Phase: N/A
Study type: Interventional

POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.

NCT ID: NCT03885310 Recruiting - Clinical trials for Esophageal Stricture

INGEST I Pilot Study

INGEST
Start date: February 24, 2019
Phase: N/A
Study type: Interventional

INGEST I Pilot study is a feasibility study for evaluating the safety and efficacy of DCBs.

NCT ID: NCT03708562 Completed - Clinical trials for Chronic Kidney Diseases

everlinQ Endovascular Access Systems Enhancements (EASE-2) Study

Start date: October 16, 2017
Phase: N/A
Study type: Interventional

Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.

NCT ID: NCT03688893 Completed - Tooth Discoloration Clinical Trials

Efficacy of Laser Application in Dental Bleaching

Start date: September 5, 2015
Phase: N/A
Study type: Interventional

Objective: To establish the efficacy of laser application with chemical treatment in dental bleaching compared to chemical treatment alone. Methods: The investigators conducted a randomized controlled trial (RCT), single blind (evaluator), in 24 patients randomized to laser and chemical intervention (12) or chemical intervention aloe (12). The commercial products used were Whiteness Hp 35% Hydrogen Peroxide and the LASER of DCM Equipments. The trial outcome measures were obtained using the Vita EasyShade Spectrophotometer and the International CIELCh system. To stablish differences before vs. after treatments and between groups, the T test and chi2 tests were applied.

NCT ID: NCT03659552 Completed - Clinical trials for Ventilator-Induced Lung Injury

Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access

Start date: May 7, 2018
Phase: N/A
Study type: Interventional

Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.

NCT ID: NCT03542123 Recruiting - Heart Failure Clinical Trials

Cardiac Output Autonomic Stimulation Therapy for Heart Failure - Hemodynamic Effects

COAST-HF FX
Start date: June 5, 2018
Phase: N/A
Study type: Interventional

A single-arm study to observe NeuroTronik Cardiac Autonomic Nerve Stimulation (CANS) Therapy System hemodynamic and other physiologic effects.

NCT ID: NCT03228381 Completed - Heart Failure Clinical Trials

The BOSS Study: An Acute Evaluation of Anatomical and Geometric Changes Using the Bladder on a Stick System (BOSS)

BOSS
Start date: August 21, 2017
Phase: N/A
Study type: Interventional

The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.

NCT ID: NCT02880683 Completed - Cardiac Output, Low Clinical Trials

Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

COAST-HF HNrCS
Start date: October 2015
Phase: N/A
Study type: Interventional

A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

NCT ID: NCT02832544 Recruiting - Clinical trials for Rheumatic Heart Disease

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority

INVICTUS-VKA
Start date: August 22, 2016
Phase: Phase 3
Study type: Interventional

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.