NCT00732719

Compression Device Safety Study on Edema

A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: ConvaTec Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety of the prototype Compression Device in subjects with Oedema

Conditions

• Edema

Interventions

Type	Name	Description
DEVICE	Prototype device (unnamed) worn-no pressure given (placebo) from inflatable cuffs
DEVICE	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
DEVICE	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
DEVICE	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
DEVICE	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
DEVICE	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs
DEVICE	Prototype device(unnamed)-A battery operated inflatable pneumatic cuffs

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-11-01
• Completion: 2004-12-01
• First posted: 2008-08-12
• Last updated: 2008-10-31

Locations

1 site across 1 country: Germany