Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR)

This study has been completed.

Sponsor:

Information provided by:

Acclarent

ClinicalTrials.gov Identifier:

NCT00231062

First received: September 30, 2005

Last updated: June 10, 2011

Last verified: June 2011

History of Changes

Results First Received: April 29, 2011

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:	Chronic Sinusitis
Intervention:	Device: Sinuplasty

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
Recruited from 3/2005 to 12/2005 in physician practice

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Balloon Dilation of Sinus Ostia	No text entered.

Participant Flow: Overall Study

	Balloon Dilation of Sinus Ostia
STARTED	115
COMPLETED	109
NOT COMPLETED	6
Physician Decision	6

Baseline Characteristics

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Reporting Groups

	Description
Balloon Dilation of Sinus Ostia	No text entered.

Baseline Measures

	Balloon Dilation of Sinus Ostia
Number of Participants [units: participants]	115
Age [units: participants]
<=18 years	0
Between 18 and 65 years	102
>=65 years	13
Age [units: years] Mean ± Standard Deviation	47.8 ± 12.59
Gender [units: participants]
Female	74
Male	41
Region of Enrollment [units: participants]
United States	115

Outcome Measures

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1. Primary:

Number of Sinuses With Patency of Sinus Ostium After Sinuplasty [ Time Frame: 24 weeks ]

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2. Primary:

Number of Participants With Adverse Events Following Sinuplasty Procedure [ Time Frame: 24 weeks ]

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3. Secondary:

Number of Participants Experiencing Relief of Sinus Symptoms [ Time Frame: Week 24 ]

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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: If requested by Sponsor, Investigator(s) shall delay the submission of any publication or presentation for up to sixty (60) days from the date of Sponsor’s request to permit the preparation and filing of related patent applications by Sponsor or for Sponsor to take other steps to protect its intellectual property interests.

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
No text entered.

Results Point of Contact:

Name/Title: Laura England, Manager-Clinical Affairs
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:	NCT00231062 History of Changes
Other Study ID Numbers:	CP-00313
Study First Received:	September 30, 2005
Results First Received:	April 29, 2011
Last Updated:	June 10, 2011
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

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