Abdominal AdhesionsNCT00665730
Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
A study testing Sepraspray in people with Abdominal Adhesions, run by Genzyme, a Sanofi Company at 6 sites in 5 countries.
Trial summary
This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Adhesions
- What is being tested?
- Sepraspray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Jul 2007to Jun 2008
- 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 who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.
Who cannot join
- Patients who are pregnant.
- Patients with ongoing abdominal abscess.
- Patients with ongoing bacterial peritonitis.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
About this study
Official title: Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)
This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.
- Conditions
- Abdominal Adhesions
- Being tested
- Sepraspray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprasprayDevice
| Study group | Role | What they receive |
|---|---|---|
| Sepraspray | Experimental | Sepraspray Powder applied on the viscera directly under the midline incision followed by incision closure. Sepraspray dose applied was between 2 g and 4 g per patient. Receives: Device: Sepraspray |
| Control | No intervention | No anti-adhesion treatment used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
Measured: 8-14 weeks
Secondary outcomes (2)
Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.
Measured: 8-14 weeks
Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.
Measured: 8-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Study terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal AdhesionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 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
- NCT00665730
- Sponsor's protocol ID
- SSPRAY00406
- Status last verified
- May 2015
- First submitted
- 23 Apr 2008
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)
- ClinicalTrials.gov ID
- NCT00665730
- Acronym / sponsor ID
- SSPRAY00406
- Conditions
- Abdominal Adhesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low enrollment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Apr 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 safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepraspray | Experimental | Device: SepraspraySepraspray Powder applied on the viscera directly under the midline incision followed by incision closure. Sepraspray dose applied was between 2 g and 4 g per patient. |
| Control | No intervention | –No anti-adhesion treatment used. |
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 who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.
Key exclusion criteria (3 listed)
- Patients who are pregnant.
- Patients with ongoing abdominal abscess.
- Patients with ongoing bacterial peritonitis.
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 |
|---|---|---|
| Sepraspray | Device | Sepraspray |
Primary outcome
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
Time frame: 8-14 weeks
2 secondary outcomes
Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.
Time frame: 8-14 weeks
Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.
Time frame: 8-14 weeks
Results and safety
The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sepraspray in people with Abdominal Adhesions, run by Genzyme, a Sanofi Company at 6 sites in 5 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 3 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 8 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 6 sites in Czechia, Denmark, France, Germany, United Kingdom. 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: Study terminated due to low enrollment.). 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?
Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision (time frame: 8-14 weeks). 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 8 May 2015.