Validity Study of a Nasal Valve Implant
This study is enrolling participants by invitation only.
Sponsor:
Nasoform, LLC
Information provided by:
Nasoform, LLC
ClinicalTrials.gov Identifier:
NCT00837525
First received: February 4, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2009 | ||||
| Last Updated Date | February 4, 2009 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Nasal obstruction symptom scale [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validity Study of a Nasal Valve Implant | ||||
| Official Title ICMJE | Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse. | ||||
| Brief Summary | The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Nasal Valve Collapse | ||||
| Intervention ICMJE | Procedure: nasal valve implant
Injectable implantation of a biodegradable material for support of the Nasal valve. |
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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 | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 4 | ||||
| Estimated Completion Date | June 2010 | ||||
| Estimated Primary Completion Date | May 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 and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00837525 | ||||
| Other Study ID Numbers ICMJE | NVB | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Iyad Saidi, Nasoform | ||||
| Study Sponsor ICMJE | Nasoform, LLC | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nasoform, LLC | ||||
| Verification Date | February 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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