Vesico-vaginal FistulaVVPNCT00923338
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
A study testing Surgisis Biodesign (Vesico-vaginal fistula plug) in people with Vesico-vaginal Fistula, run by Cook Group Incorporated at 1 site in Uganda.
Trial summary
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma. Read more about this study
- Who is it for?
- Ages 10 years and older, women only
- Conditions the study is for
- Vesico-vaginal Fistula
- What is being tested?
- Surgisis Biodesign (Vesico-vaginal fistula plug)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2009to Apr 2012
- 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 10 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has signed and dated the informed consent.
- Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.
- Patient agrees to follow-up schedule.
- Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.
- Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.
Who cannot join
- Patient is not medically fit enough for surgery under general or spinal anesthesia.
- Patient is a "mature minor" as defined by Ugandan law.
- Patient is pregnant, breastfeeding or planning further pregnancy during the study period.
- Patient has physical allergies or cultural objections to the receipt of porcine products.
- Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.
- Patient has spina bifida or other neural tube defect.
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- Patient has interstitial cystitis or other chronic pelvic pain syndrome.
- Patient has signs of acute or chronic pelvic inflammation, active urinary tract infection not responsive to antibiotic treatment, vaginal infection, or abscess of the fistula tract.
- Patient presents with clinically diagnosed sepsis (for whatever reason).
- Patient has concomitant ureterovaginal fistula.
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.
- Conditions
- Vesico-vaginal Fistula
- Being tested
- Surgisis Biodesign (Vesico-vaginal fistula plug)
- Keywords
- fistula, vesico-vaginal fistula
- Medical subject headings
- Vesicovaginal Fistula, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgisis Biodesign (Vesico-vaginal fistula plug)Device
Also called SurgiSIS Biodesign
Vesico-vaginal fistula plug
| Study group | Role | What they receive |
|---|---|---|
| Vesico-vaginal fistula plug | Experimental | Vesico-vaginal fistula plug Receives: Device: Surgisis Biodesign (Vesico-vaginal fistula plug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula
Measured: 4 months
Adverse Events
Measured: 4 months
Secondary outcomes (1)
Improvement in quality of life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesico-vaginal FistulaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Musa Kayondo, MD, Principal investigator, Mbarara University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923338
- Sponsor's protocol ID
- 09-006
- Other IDs
- 350012
- Acronym
- VVP
- Status last verified
- Jul 2012
- First submitted
- 16 Jun 2009
- Last updated
- 31 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
- ClinicalTrials.gov ID
- NCT00923338
- Acronym / sponsor ID
- VVP / 09-006
- Conditions
- Vesico-vaginal Fistula
- Keywords
- fistula, vesico-vaginal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Jun 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.
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vesico-vaginal fistula plug | Experimental | Device: Surgisis Biodesign (Vesico-vaginal fistula plug)Vesico-vaginal fistula plug |
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has signed and dated the informed consent.
- Patient is 18 years old; or is an emancipated minor as defined by Ugandan law or is under 18 but has a parent/guardian who provides informed consent.
- Patient agrees to follow-up schedule.
- Patient presents with a leaking vesico-vaginal fistula, confirmed by exam, with no signs of acute inflammation, no signs of active urinary tract infection that cannot be controlled with a standard pre-operative course of antibiotics, no signs of vaginal infection, or no signs of abscess.
- Patient presents with a fistula of a size and in a location that may be reasonably treated with the VVP device.
Key exclusion criteria (10 listed)
- Patient is not medically fit enough for surgery under general or spinal anesthesia.
- Patient is a "mature minor" as defined by Ugandan law.
- Patient is pregnant, breastfeeding or planning further pregnancy during the study period.
- Patient has physical allergies or cultural objections to the receipt of porcine products.
- Patient has an active sexually transmitted disease, is HIV-positive, or any other active systemic infection that may interfere with healing.
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 |
|---|---|---|
| Surgisis Biodesign (Vesico-vaginal fistula plug)Also: SurgiSIS BiodesignVesico-vaginal fistula plug | Device | Vesico-vaginal fistula plug |
Primary outcome
Fistula
Time frame: 4 months
Adverse Events
Time frame: 4 months
1 secondary outcome
Improvement in quality of life
Time frame: 4 months
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 31 Dec 2015.
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.
Musa Kayondo, MD principal investigator
Mbarara University Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgisis Biodesign (Vesico-vaginal fistula plug) in people with Vesico-vaginal Fistula, run by Cook Group Incorporated at 1 site in Uganda.
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 5 inclusion and 10 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 31 Dec 2015. 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 Uganda. 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?
Fistula (time frame: 4 months). The study lists 2 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 31 Dec 2015.