Trials / Terminated
TerminatedNCT00778479
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 155 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sepraspray | Max. 10g of Sepraspray |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2008-10-23
- Last updated
- 2015-03-24
Locations
7 sites across 2 countries: France, Sweden
Source: ClinicalTrials.gov record NCT00778479. Inclusion in this directory is not an endorsement.