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Safety and Efficacy of a Novel Carpal Tunnel Tissue Manipulation Device in Treating Carpal Tunnel Syndrome

NCT02534493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-12-02

Study results available
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Summary

A single-center, prospective, non-randomized study to evaluate the safety and efficacy of a novel carpal tunnel tissue manipulation device in treating symptoms and decreased physical function in subjects previously diagnosed with mild to severe carpal tunnel syndrome (CTS).

Conditions

  • Carpal Tunnel Syndrome

Interventions

DEVICE

Carpal Tunnel Tissue Manipulation Device (CTMD)

This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.

Sponsors & Collaborators

  • Pressure Profile Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Frank J. King, M.D. · Mission Pain and Spine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • United States

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 NCT02534493 on ClinicalTrials.gov