Pilot Study of NASHA/Dx Gel for Fecal Incontinence
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Uppsala University Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Uppsala University Hospital
Information provided by:
Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT00971269
First received: September 2, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 2, 2009 | ||||
| Last Updated Date | September 2, 2009 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in fecal incontinence episodes [ Time Frame: Follow up during a four week period and after 6 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Side effects related to treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Study of NASHA/Dx Gel for Fecal Incontinence | ||||
| Official Title ICMJE | A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Fecal Incontinence | ||||
| Intervention ICMJE | Device: Solesta (Nasha/Dx)
Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks
Other Name: Solesta |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 16 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00971269 | ||||
| Other Study ID Numbers ICMJE | EPN 2008/066 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Professor Wilhelm Graf, Dept of Surgery, Uppsala University Hospital | ||||
| Study Sponsor ICMJE | Uppsala University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Uppsala University Hospital | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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