Evaluation of the Safety of Sepraspray in Open Abdominal... | NCT00778479

Studies
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

NCT00778479

Sponsor

Genzyme, a Sanofi Company

Status

Terminated

Last Update Posted

Mar 24, 2015Estimated

Enrollment

155Actual

Phase

Not Applicable

Conditions

Adhesion Prevention (Abdominal)

Interventions

Sepraspray

Countries

France
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated by Sponsor: see details below

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 22, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2015

Last Update Posted Date

Mar 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

155Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sepraspray	Experimental	Receive Sepraspray	Device: Sepraspray
Control	No Intervention	no treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sepraspray	Device	Max. 10g of Sepraspray	Sepraspray

Measure	Description	Time Frame
Morbidity		30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years old and over that require open abdominal surgery

Exclusion Criteria:

Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Hotel Dieu		Clamond			France
CHRU de Lille, Hopital Huriez