At a glance
ClinicalIndex Comparison RecordN/ACompleted· 115 enrolled
Drug / intervention
Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
In Brief
A clinical study evaluating Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) for Fecal Incontinence. Completed, enrolled 115 participants across 15 sites in 7 countries.
Detailed Summary
The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence
CountriesCanada, Finland, France, Germany, Italy, Norway, Spain
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
Primary CompletionNov 2009
First PostedApr 2010
Study CompletionDec 2010
TodayJul 2026
First PostedApr 27, 2010
Enrollment StartNov 1, 2007
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.2 years ago
Interventions
Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)device