Healthy Volunteer Study (IPSHS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Acclarent.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Acclarent
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT01346332
First received: April 29, 2011
Last updated: May 9, 2011
Last verified: May 2011
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 29, 2011 | ||||||||
| Last Updated Date | May 9, 2011 | ||||||||
| Start Date ICMJE | April 2011 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain scores on visual analog scale [ Time Frame: Day 1 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01346332 on ClinicalTrials.gov Archive Site | ||||||||
| 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 | Healthy Volunteer Study | ||||||||
| Official Title ICMJE | Performance of the Iontophoresis System With Headset in Healthy Volunteers | ||||||||
| Brief Summary | The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Otitis Media | ||||||||
| Intervention ICMJE | Device: Iontophoresis System with Headset
Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset |
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| Study Arm (s) | Experimental: Anesthetization
Intervention: Device: Iontophoresis System with Headset |
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| 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 | 20 | ||||||||
| Estimated Completion Date | September 2011 | ||||||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 2 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01346332 | ||||||||
| Other Study ID Numbers ICMJE | CPR005021 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | R. Kehl Sink, Acclarent, Inc. | ||||||||
| Study Sponsor ICMJE | Acclarent | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Acclarent | ||||||||
| Verification Date | May 2011 | ||||||||
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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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