Study to Evaluate Safety and Effectiveness of Spinal Sealant

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Covidien ( Confluent Surgical )

ClinicalTrials.gov Identifier:

NCT00594035

First received: January 2, 2008

Last updated: June 20, 2012

Last verified: June 2012

History of Changes

Results First Received: October 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Spinal Procedure Requiring Dura Incision
Interventions:	Device: Spinal Sealant System Device: Standard of care

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
Subjects scheduled for spinal procedures requiring a dural incision were considered for study participation. The Study involved 24 investigational sites within the United States. Subjects were recruited from neurosurgery practices between the period of 01 September 2005 (first subject consented) to 06 Feb 2008 (last visit date).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment was considered the point of randomization. Subjects were randomized intra-operatively after confirmation that all pre-operative and intra-operative eligibility criteria had been met.

Reporting Groups

	Description
Spinal Sealant	Subjects that recieve DuraSeal Spinal Sealant
Standard of Care	Subjects who receive standard or care meathods of dural sealing

Participant Flow: Overall Study

	Spinal Sealant	Standard of Care
STARTED	102 ^[1]	56 ^[2]
COMPLETED	100 ^[3]	53 ^[4]
NOT COMPLETED	2	3
Lost to Follow-up	1	1
Withdrawal by Subject	1	0
Subject transferred to nursing home	0	1
Subject couldn't return due to job	0	1

[1]	102 subjects were randomized to Spinal Sealant
[2]	56 subjects were randomized to the control group (standard of care)
[3]	100 Spinal Sealant subjects were evaluable at the 90-day visit
[4]	53 control group subjects were evaluable at the 90-day visit

Baseline Characteristics

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Reporting Groups

	Description
Spinal Sealant	Subjects that recieve DuraSeal Spinal Sealant
Standard of Care	Subjects who receive standard or care meathods of dural sealing
Total	Total of all reporting groups

Baseline Measures

	Spinal Sealant	Standard of Care	Total
Number of Participants [units: participants]	102	56	158
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	89	52	141
>=65 years	13	4	17
Age [units: years] Mean ± Standard Deviation	47.7 ± 13.6	42.3 ± 14.5	45.8 ± 14.1
Gender [units: participants]
Female	54	30	84
Male	48	26	74
Region of Enrollment [units: participants]
United States	102	56	158

Outcome Measures

1. Primary:

Watertight Dural Closure [ Time Frame: Intra-Operative ]

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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: The sponsor can review results at least 30 days prior to public release, and at the request of Sponsor, the PI will withhold submission for an additional period, not to exceed 90 days. The first publication of the study results shall be made in conjunction with a joint, multi-center publication of the results. If a multi-center publication is not submitted within 12 months after the conclusion of the Study, the PIs may publish the results from their individual site.

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: Jennifer Doyle, MS, CCRA- Global Director, Clinical Affairs- Biosurgery
Organization: Covidien
phone: 781-839-1770
e-mail: jennifer.doyle@covidien.com

No publications provided

Responsible Party:	Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:	NCT00594035 History of Changes
Other Study ID Numbers:	DRS-05-001
Study First Received:	January 2, 2008
Results First Received:	October 30, 2009
Last Updated:	June 20, 2012
Health Authority:	United States: Food and Drug Administration

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