Adhesion PreventionC-MUSTNCT00813397
Manageability and Safety Assessment of Sepraspray in Abdominal Surgery.
A study testing Sepraspray in people with Adhesion Prevention, run by Genzyme, a Sanofi Company at 15 sites in France.
Trial summary
This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesion Prevention
- What is being tested?
- Sepraspray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 15 sitesFrance
- Study dates
- Sep 2008to Jul 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 laparoscopic abdominal surgery
Who cannot join
- Patients who are pregnant or have an ongoing infectious complications from a previous surgery
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU Amiens Nord
Amiens, 80054
Hopital Avicenne
Bobingy, 93009
Hopital Beaujon
Clichy, 92110
Centre Hospitalier Simone Veil
Eaubonne, 95602
Hopital Nord
Marseille, 13915
CHR Nantes-Hopital Hotel Dieu
Nantes, 44093
CHU Hopital de le'Archet
Nice, 06200
Institut Mutualiste Montsouris
Paris, 75014
CHU Bordeaux-Hopital du Haut Leveque
Pessac, 33604
CHU Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Intercommunal de Poissy Saint-German
Poissy, 78300
CHU Charles Nicolle
Rouen, 76031
CHU Bordeaux Saint Andre
Talence, 33404
Hopital Purpan
Toulouse, 31509
CHU Hopital Trousseau
Tours, 37044
About this study
Official title: Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery
This study will examine the performance of SeprasSpray in patients undergoing abdominal surgery (laparoscopic).
- Conditions
- Adhesion Prevention
- 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, No Placebo |
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 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesion PreventionStudies 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
- 210 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
- NCT00813397
- Sponsor's protocol ID
- SSPRAY00608
- Acronym
- C-MUST
- Status last verified
- May 2015
- First submitted
- 19 Dec 2008
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.
PubMed 25348087
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manageability and Safety Assessment of the SepraSpray Anti-adhesion Barrier in Abdominal Coelioscopic Surgery
- ClinicalTrials.gov ID
- NCT00813397
- Acronym / sponsor ID
- C-MUST / SSPRAY00608
- Conditions
- Adhesion Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Dec 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 SeprasSpray in patients undergoing abdominal surgery (laparoscopic).
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, No Placebo |
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 laparoscopic abdominal surgery
Key exclusion criteria (1 listed)
- Patients who are pregnant or have an ongoing infectious complications from a previous surgery
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Derived from this study: PubMed 25348087Berdah SV, Mariette C, Denet C, Panis Y, Laurent C, Cotte E, Huten N, Le Peillet Feuillet E, Duron JJ. A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery. Trials. 2014 Oct 27;15:413. doi: 10.1186/1745-6215-15-413.
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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
15 sites in 1 country: 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, run by Genzyme, a Sanofi Company at 15 sites in France.
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: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT00813397, which also lists 1 linked publication.
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 22 May 2015.