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Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients

NCT02324400 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-12-24

No results posted yet for this study

Summary

The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.

Conditions

  • Heart Decompensation
  • Heart Failure, Congestive
  • Renal Insufficiency

Interventions

DEVICE

RenaSense Stimulation

RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall

DEVICE

RenaSense Sham Control

RenaSense Catheter,no delivery of stimulation

Sponsors & Collaborators

  • Nephera Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02324400 on ClinicalTrials.gov