Pelvic Organ ProlapsePOPNCT01827774
Soft Tissue Graft for Repair of Pelvic Organ Prolapse
A study testing Surgisis® Soft Tissue Graft in people with Pelvic Organ Prolapse, run by Cook Group Incorporated at 1 site in China.
Trial summary
The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Surgisis® Soft Tissue Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to 17 Apr 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
- POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
- At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)
Who cannot join
- Age < 18 years
- BMI > 40
- Not medically fit for transvaginal surgery under general or spinal anesthesia
- Active UTI at the time of the index procedure as determined by urine culture
- Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
- Prior placement of synthetic mesh or biologic graft for pelvic organ prolapse
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- A history of cervical, ovarian, uterine, endometrial, vaginal, vulval, colon, rectal or bladder cancer
- Currently planned obliterative surgical repair for pelvic organ prolapse
- Systemic infection at the time of surgery
- Requires chronic immunosuppressive therapy, including steroids or cytotoxic agents
- Pregnant, breastfeeding or planning pregnancy during the study period
- Previous diagnosis of collagen disorder (i.e., Marfan's, Ehlers-Danlos)
- Physical allergies or cultural objections to the receipt of porcine products
- Life expectancy of less than 12 months
- Ongoing participation in an investigational device or drug trial
- Currently undergoing evaluation or treatment for chronic pelvic pain (e.g., pain as a result of interstitial cystitis, endometriosis, vulvodynia, pelvic congestion syndrome)
- Active vaginal infection at the time of the index procedure
- History of pelvic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse
The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Surgisis® Soft Tissue Graft
- Keywords
- Pelvic organ prolapse, Graft repair
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgisis® Soft Tissue GraftDevice
Surgisis® Soft Tissue Graft for pelvic organ prolapse repair
| Study group | Role | What they receive |
|---|---|---|
| Surgisis® Soft Tissue Graft | Experimental | Not described Receives: Device: Surgisis® Soft Tissue Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence of pelvic organ prolapse
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 posted10 Apr 2013 (estimated)
- Study startMar 2013
- Primary completion17 Apr 2017
- Study completion17 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827774
- Sponsor's protocol ID
- 12-015
- Acronym
- POP
- Status last verified
- Feb 2018
- First submitted
- 3 Apr 2013
- Last updated
- 15 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of Surgisis® Soft Tissue Graft for Repair of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01827774
- Acronym / sponsor ID
- POP / 12-015
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic organ prolapse, Graft repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 10 Apr 2013 (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 collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgisis® Soft Tissue Graft | Experimental | Device: Surgisis® Soft Tissue Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in need of transvaginal surgical repair of primary (i.e., de novo) pelvic organ prolapse.
- POPQ = stage 2 or 3 in the vaginal compartment with the leading edge of prolapse (i.e., more severe prolapse)
- At least one symptom associated with prolapse (e.g., any of the following including but not limited to vaginal bulge, vaginal pain/discomfort, voiding dysfunction, manual reduction (digitation) needed for defecation, fecal incontinence, dyspareunia)
Key exclusion criteria (18 listed)
- Age < 18 years
- BMI > 40
- Not medically fit for transvaginal surgery under general or spinal anesthesia
- Active UTI at the time of the index procedure as determined by urine culture
- Vaginal atrophy (Note: Patient may be included after vaginal atrophy has been effectively treated.)
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® Soft Tissue GraftSurgisis® Soft Tissue Graft for pelvic organ prolapse repair | Device | Surgisis® Soft Tissue Graft |
Primary outcome
Rate of recurrence of pelvic organ prolapse
Time frame: 12 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 15 Feb 2018.
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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.
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® Soft Tissue Graft in people with Pelvic Organ Prolapse, run by Cook Group Incorporated at 1 site in China.
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 18 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 15 Feb 2018. 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 China. 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?
Rate of recurrence of pelvic organ prolapse (time frame: 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 15 Feb 2018.