NCT00971269

Pilot Study of NASHA/Dx Gel for Fecal Incontinence

A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Uppsala University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Solesta (Nasha/Dx)	Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2011-06-01
• First posted: 2009-09-03
• Last updated: 2009-09-03

Locations

1 site across 1 country: Sweden