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Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke

NCT03733236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-07-25

No results posted yet for this study

Summary

The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.

The secondary objectives of this study are to examine the effectiveness of the ISS500 System implantation in the treatment of acute ischemic stroke.

Conditions

  • Ischemic Stricture of Intestine

Interventions

DEVICE

ISS Active Stimulation

ISS SPG stimulation and standard of care

Sponsors & Collaborators

  • BrainsGate

    lead INDUSTRY

Principal Investigators

  • Subash Kaul, Dr. · Nizam's Institute of Medical Research Punjagutta, Hyderabad.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-07-06
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • India

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 NCT03733236 on ClinicalTrials.gov