Clinical Evaluation of the Ethmoid Sinus Spacer (SPACER)

This study has been completed.

Sponsor:

Information provided by:

Acclarent

ClinicalTrials.gov Identifier:

NCT01054703

First received: January 20, 2010

Last updated: June 10, 2011

Last verified: June 2011

History of Changes

Results First Received: February 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Sinusitis, Chronic Rhinosinusitis
Intervention:	Device: Ethmoid Sinus Spacer

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Ethmoid Sinus Spacer Placement	Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40

Participant Flow: Overall Study

	Ethmoid Sinus Spacer Placement
STARTED	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Ethmoid Sinus Spacer Placement	Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40

Baseline Measures

	Ethmoid Sinus Spacer Placement
Number of Participants [units: participants]	14
Age [units: participants]
<=18 years	0
Between 18 and 65 years	14
>=65 years	0
Age [units: years] Mean ± Standard Deviation	50.1 ± 9.6
Gender [units: participants]
Female	5
Male	9
Region of Enrollment [units: participants]
United States	14

Outcome Measures

1. Primary:

Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant [ Time Frame: Procedural and 6 weeks post-implant ]

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2. Secondary:

Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures [ Time Frame: 1 wk, 2wk, 4wk, 6wk ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Principal investigator shall not issue or disseminate any press release or statement, nor initiate or cause to be initiated any communication of information regarding the clinical trial (written or oral) to the communications media or third parties without the prior written consent of Sponsor.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Laura England, Manager-Clinical Research
Organization: Acclarent
phone: 650-687-4466
e-mail: lenglan1@its.jnj.com

No publications provided

Responsible Party:	Laura England, Manager- Clinical Affairs, Acclarent, Inc.
ClinicalTrials.gov Identifier:	NCT01054703 History of Changes
Other Study ID Numbers:	CPR02082
Study First Received:	January 20, 2010
Results First Received:	February 8, 2010
Last Updated:	June 10, 2011
Health Authority:	United States: Institutional Review Board

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