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NCT01488786 · ClinicalTrials.gov registry record · NA

A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind

A NA study of Blindness, sponsored by Wicab.

Completed
Registry status
NA
Development phase
75
Enrollment target
7
Study locations

NCT01488786: Completed NA study of Blindness, sponsored by Wicab.

NCT01488786 is a NA study of Blindness that has completed, run by Wicab. The registered enrollment target is 75 participants, above the 48-participant average among 7 other Blindness trials with a reported enrollment target (56% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01488786, a NA study of Blindness, has completed, sponsored by Wicab.

COMPLETED
Registry status
NA
Development phase
75 participants
Enrollment target
7
Study locations

Study Summary

The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.

Primary Outcome

The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%.

Conditions Studied

Interventions

  • DEVICE BrainPort Vision Device

Study Locations (7)

Florida

  • Independence for the Blind of West Florida Inc. - Pensacola

Illinois

  • The Chicago Lighthouse for People Who Are Blind and Visually Impaired - Chicago

Kansas

  • Envision - Wichita

Louisiana

  • Ochsner Clinic Foundation - New Orleans

New York

  • Lighthouse International - New York

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Other

  • Canadian National Institute for the Blind - Toronto

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2011-10
Est. Completion 2013-04
Phase NA
Wicab

4 total trials

What the finished NCT01488786 record still lists

NCT01488786 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 48-participant average among 7 other Blindness trials with a reported enrollment target (56% higher).

The record links to 1 condition, with Blindness appearing as the primary indexed condition, and to 1 intervention - of which BrainPort Vision Device is the first listed.

NCT01488786 lists 7 locations in 7 states (Florida, Illinois, Kansas).

Frequently Asked Questions

What is clinical trial NCT01488786 about?

NCT01488786 is a clinical study titled "A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind". The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.

What is the current status of trial NCT01488786?

This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2011-10. Estimated completion is 2013-04.

What conditions does trial NCT01488786 study?

This clinical trial studies the following conditions: Blindness.

What interventions are being tested in trial NCT01488786?

The interventions under investigation include: BrainPort Vision Device (DEVICE).

Who is sponsoring clinical trial NCT01488786?

This trial is sponsored by Wicab, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01488786 being conducted?

This trial has 7 study locations across Florida, Illinois, Kansas, Louisiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01488786, the US trial registry maintained by the National Library of Medicine. NCT01488786 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.