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Study to Evaluate Solesta for Treatment of Fecal Incontinence

NCT01110681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2022-08-26

Study results available
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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.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Principal Investigators

  • Head of Medical Affairs Q-Med AB · Galderma R&D

  • Tom Oresland, MD · Akershus University Hospital, Lorenskog, Norway

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-11-30
Completion
2010-12-31

Countries

  • Canada
  • Finland
  • France
  • Germany
  • Italy
  • Norway
  • Spain

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 NCT01110681 on ClinicalTrials.gov