NCT02534493

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Pressure Profile Systems, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-08-27
• Last updated: 2017-12-02
• Results posted: 2017-12-02

Locations

1 site across 1 country: United States