Fecal IncontinencePhase 1/2NCT00971269
Pilot Study of NASHA/Dx Gel for Fecal Incontinence
A Phase 1/2 study testing Solesta (Nasha/Dx) in people with Fecal Incontinence, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Solesta (Nasha/Dx)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Jun 2011
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fecal incontinence with at least 2 episodes/week
- Symptom duration at least one year
- Failed attempt of conservative therapy
- Age 18-80
- Written informed consent
- Available for follow-up
- Fully compliant with protocol
Who cannot join
- Active inflammatory bowel disease
- Total external sphincter defect at ultrasound and clinical examination
- Bleeding diathesis or anticoagulant therapy
- Rectal prolapse or intussusceptions
- Present anal sepsis
- Anorectal implants
Show all 9Show fewer
- Recent anorectal surgery (within 6 months)
- Rectal anastomosis
- Pregnancy, postpartum (one year) or breast feeding
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Surgery, University Hospital
751 82 Uppsala
Wilhelm JR Graf, MD PhD
About this study
Official title: A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
The study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.
- Conditions
- Fecal Incontinence
- Being tested
- Solesta (Nasha/Dx)
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solesta (Nasha/Dx)Device
Also called Solesta
Gel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal incontinence episodes
Measured: Follow up during a four week period and after 6 and 12 months
Secondary outcomes (1)
Side effects related to treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971269
- Sponsor's protocol ID
- EPN 2008/066
- Status last verified
- Sep 2009
- First submitted
- 2 Sep 2009
- Last updated
- 3 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Intersphincteric Injection of NASHA/Dx Gel for Fecal Incontinence
- ClinicalTrials.gov ID
- NCT00971269
- Acronym / sponsor ID
- EPN 2008/066
- Conditions
- Fecal Incontinence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 3 Sep 2009 (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 study is an open, prospective, single-site study where 16 patients suffering from fecal incontinence will be included. Change in fecal incontinence episodes after intersphincteric injection of NASHA/Dx gel 4x2 ml and retreatment 4x2 ml after 4 weeks will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fecal incontinence with at least 2 episodes/week
- Symptom duration at least one year
- Failed attempt of conservative therapy
- Age 18-80
- Written informed consent
Key exclusion criteria (9 listed)
- Active inflammatory bowel disease
- Total external sphincter defect at ultrasound and clinical examination
- Bleeding diathesis or anticoagulant therapy
- Rectal prolapse or intussusceptions
- Present anal sepsis
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 |
|---|---|---|
| Solesta (Nasha/Dx)Also: SolestaGel (hyaluronic acid/dextranomer) for intersphincteric injection 4x2 ml and retreatment 4x2 ml after 4 weeks | Device | – |
Primary outcome
Change in fecal incontinence episodes
Time frame: Follow up during a four week period and after 6 and 12 months
1 secondary outcome
Side effects related to treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Solesta (Nasha/Dx) in people with Fecal Incontinence, run by Uppsala University Hospital at 1 site in Sweden.
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 7 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: status not confirmed, as of the sponsor's last update on 3 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilhelm JR Graf, MD PhD (+46(0)18 611 46 06, wilhelm.graf@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fecal incontinence episodes (time frame: Follow up during a four week period and after 6 and 12 months). 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 3 Sep 2009.