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A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usability of the I-Port Injection Port

NCT00486109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2008-03-11

No results posted yet for this study

Summary

This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a new disposable injection port through which prescribed medication is injected subcutaneously from a standard syringe or pen. Additional investigation compared subject opinion towards using the I-PORT™ device compared to standard injection therapy.

Conditions

Interventions

DEVICE

I-Port(TM) Injection Port

Sponsors & Collaborators

  • Medstar Health Research Institute

    collaborator OTHER

  • Valeritas, Inc.

    collaborator INDUSTRY

  • Patton Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sherwyn Schwartz, M.D. · Diabetes and Glandular Disease Clinic

  • Bruce Bode, M.D. · Atlanta Diabetes Associates

  • Thomas Blevins, M.D. · Texas Diabetes & Endocrinology

  • Stephen Aronoff, M.D. · Research Institute of Dallas

  • Claire Baker, M.D. · Diabetes and Endocrine Associates

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Completion
2007-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00486109 on ClinicalTrials.gov