Fecal IncontinencePhase 2NCT00762047
A Prospective, Multi-center, Randomized, Blinded Study to Evaluate Durasphere FI for the Treatment of Fecal Incontinence
A Phase 2 study testing Durasphere FI in people with Fecal Incontinence, run by Carbon Medical Technologies.
Trial summary
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Durasphere FI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 2009
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of fecal incontinence;
- Incontinence episodes over a 14-day period;
- Eighteen years of age or older;
Who cannot join
- Abnormalities of the external sphincter greater than 10 mm;
- Fibrosis of the tissue at the likely injection sites;
- Has a condition that could lead to significant postoperative complications
- Rectal varices;
- Cancer of the rectum or colon, undergoing active treatment;
- Crohn's disease or ulcerative colitis;
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- Chronic diarrhea unmanageable by drugs and/or diet;
- Rectal bleeding;
- Pregnant or within one year postpartum.
About this study
Official title: Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.
- Conditions
- Fecal Incontinence
- Being tested
- Durasphere FI, Sham
- Keywords
- Fecal Incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durasphere FIDevice
Durasphere Injection
ShamDevice
Sham injection with anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Durasphere | Experimental | Not described Receives: Device: Durasphere FI |
| Sham | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Measured: 6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
Measured: Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJun 2004
- Primary completionAug 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carbon Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762047
- Sponsor's protocol ID
- P1004
- Status last verified
- Jan 2012
- First submitted
- 29 Sep 2008
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 IDE Study of Durasphere FI in the Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT00762047
- Acronym / sponsor ID
- P1004
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Carbon Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 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.
The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions.
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durasphere | Experimental | Device: Durasphere FI |
| Sham | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of fecal incontinence;
- Incontinence episodes over a 14-day period;
- Eighteen years of age or older;
Key exclusion criteria (9 listed)
- Abnormalities of the external sphincter greater than 10 mm;
- Fibrosis of the tissue at the likely injection sites;
- Has a condition that could lead to significant postoperative complications
- Rectal varices;
- Cancer of the rectum or colon, undergoing active treatment;
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 |
|---|---|---|
| Durasphere FIDurasphere Injection | Device | Durasphere |
| ShamSham injection with anesthesia | Device | Sham |
Primary outcome
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Time frame: 6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
Time frame: Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Time frame: 12 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durasphere FI in people with Fecal Incontinence, run by Carbon Medical Technologies.
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 3 inclusion and 9 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. 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?
The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score (time frame: 6 month). The study lists 3 primary outcomes in all. 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 30 Jul 2013.