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Clinical Trials/NCT00813397
NCT00813397CompletedNot Applicable

Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery

Genzyme, a Sanofi Company30 sites in 1 country210 target enrollmentStarted: September 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
210
Locations
30
Primary Endpoint
Morbidity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients 18 years old and over that require laparoscopic abdominal surgery

Exclusion Criteria

  • •Patients who are pregnant or have an ongoing infectious complications from a previous surgery

Arms & Interventions

Sepraspray

Experimental

Receive Sepraspray

Intervention: Sepraspray (Device)

Control

No Intervention

No Treatment, No Placebo

Outcomes

Primary Outcomes

Morbidity

Time Frame: 30 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Genzyme, a Sanofi Company
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (30)

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