Vaginal ProlapseELEPENCT03187574
Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse
An observational study of Vaginal Prolapse, run by Hospices Civils de Lyon.
Trial summary
Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- Elevate Ant™ and Perigee™
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Apr 2016
- Phase
- Observational
- 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
Study population: patients with grade ≥3 anterior prolapse
Who may be able to join
- symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse
Who cannot join
None listed.
About this study
Official title: A Prospective Comparison of Two Vaginal Mesh Kits in the Management of Anterior and Apical Vaginal Prolapse: Long Term-results for Apical Fixation and Quality of Life
Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined as 2-year POP-Q ≤1. Secondary endpoints were function and complications.
- Conditions
- Vaginal Prolapse
- Being tested
- Elevate Ant™, Perigee™
- Keywords
- vaginal prolapse, mesh kit, anatomic assessment, quality of life
- Medical subject headings
- Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevate Ant™Device
Surgery with Elevate Ant™
Perigee™Device
Surgery with Perigee™
| Study group | Role | What they receive |
|---|---|---|
| Group A | group received Elevate Ant™ single-incision mesh Receives: Device: Elevate Ant™ | |
| Group B | group received Perigee™ transvaginal mesh Receives: Device: Perigee™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study startMay 2009
- Primary completionJan 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal ProlapseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gery LAMBLIN, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187574
- Sponsor's protocol ID
- 69HCL17_0356
- Acronym
- ELEPE
- Status last verified
- May 2017
- First submitted
- 13 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Two Vaginal Mesh Kits in the Management of Anterior and Apical Vaginal Prolapse: Long Term-results for Apical Fixation and Quality of Life
- ClinicalTrials.gov ID
- NCT03187574
- Acronym / sponsor ID
- ELEPE / 69HCL17_0356
- Conditions
- Vaginal Prolapse
- Keywords
- vaginal prolapse, mesh kit, anatomic assessment, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Jun 2017 (actual)
- 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.
Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined as 2-year POP-Q ≤1. Secondary endpoints were function and complications.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Elevate Ant™group received Elevate Ant™ single-incision mesh |
| Group B | – | Device: Perigee™group received Perigee™ transvaginal mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with grade ≥3 anterior prolapse
Key inclusion criteria (1 listed)
- symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Elevate Ant™Surgery with Elevate Ant™ | Device | Group A |
| Perigee™Surgery with Perigee™ | Device | Group B |
Primary outcome
comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits
Time frame: 1 year post-surgery
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 19 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Gery LAMBLIN principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Prolapse, run by Hospices Civils de Lyon.
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 0 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 19 Jun 2017. 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. 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?
comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits (time frame: 1 year post-surgery). 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 19 Jun 2017.