Adhesion Prevention (Abdominal)NCT00778479
Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
A study testing Sepraspray in people with Adhesion Prevention (Abdominal), run by Genzyme, a Sanofi Company at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesion Prevention (Abdominal)
- What is being tested?
- Sepraspray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2008to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years old and over that require open abdominal surgery
Who cannot join
- Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France4 sites
Chu Hotel Dieu
Clamond
CHRU de Lille, Hopital Huriez
Lille
Hopital de la Croix Rousse
Lyon
Hopital Lariboisiere
Paris
Sweden3 sites
University Hospital
Linköping
Karolinska University Hospital
Stockholm
Akademiska Sjukhuset
Uppsala
About this study
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
- Adhesion Prevention (Abdominal)
- Being tested
- Sepraspray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprasprayDevice
Max. 10g of Sepraspray
| Study group | Role | What they receive |
|---|---|---|
| Sepraspray | Experimental | Receive Sepraspray Receives: Device: Sepraspray |
| Control | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Terminated by Sponsor: see details below
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesion Prevention (Abdominal)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778479
- Sponsor's protocol ID
- SSPRAY00508
- Status last verified
- Mar 2015
- First submitted
- 22 Oct 2008
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety of Sepraspray in Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00778479
- Acronym / sponsor ID
- SSPRAY00508
- Conditions
- Adhesion Prevention (Abdominal)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by Sponsor: see details below
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepraspray | Experimental | Device: SeprasprayReceive Sepraspray |
| Control | No intervention | –no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years old and over that require open abdominal surgery
Key exclusion criteria (1 listed)
- Patients who are pregnant or have ongoing abdominal abscess or bacterial peritonitis or have infectious complications from a previous laparectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeprasprayMax. 10g of Sepraspray | Device | Sepraspray |
Primary outcome
Morbidity
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Terminated by Sponsor: see details below). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sepraspray in people with Adhesion Prevention (Abdominal), run by Genzyme, a Sanofi Company at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated by Sponsor: see details below). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.