Anterior Vaginal Wall ProlapseNCT02209337
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
A study testing SRS in people with Anterior Vaginal Wall Prolapse and Vaginal Apex/Uterine Prolapse, run by Lyra Medical Ltd. at 3 sites in 2 countries.
Trial summary
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse
- What is being tested?
- SRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2014to Mar 2018
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
- Patient age is between 18 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Who cannot join
- Patient is pregnant or breastfeeding
- Patient suffering from active infection (on antibiotic therapy)
- Patient planning vaginal delivery
- Patient had Previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Show all 11Show fewer
- Malignancy .
- Known hypersensitivity to PEEK and polypropylene materials.
- Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
- Tendency for hyper-scaring reaction
- Diagnosed with mental or emotional disturbance.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Israel2 sites
Mayanei HaYeshua Medical Center
Bnei Brak, 51544
Asaf HaRofeh Medical Center
Zrifin, 70300
About this study
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
- Being tested
- SRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRSDevice
| Study group | Role | What they receive |
|---|---|---|
| SRS-I | Experimental | Implantation of SRS-I Receives: Device: SRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
No device related serious adverse events
Measured: up to 12 month
Secondary outcomes (4)
Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)
Measured: up to 12 months
Improvement in POP-Q: points Aa and Ba
Measured: up to 12 month
Improvement in POP-Q point C
Measured: up to 12 months
Achieving normal urinary function
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Vaginal Wall 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyra Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gil Levi, Dr., Principal investigator, Mayanei HaYeshua Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209337
- Sponsor's protocol ID
- CD-14-005
- Status last verified
- Aug 2019
- First submitted
- 3 Aug 2014
- Last updated
- 16 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT02209337
- Acronym / sponsor ID
- CD-14-005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lyra Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Aug 2014 (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.
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRS-I | Experimental | Device: SRSImplantation of SRS-I |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
- Patient age is between 18 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Key exclusion criteria (11 listed)
- Patient is pregnant or breastfeeding
- Patient suffering from active infection (on antibiotic therapy)
- Patient planning vaginal delivery
- Patient had Previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic or respiratory diseases).
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 |
|---|---|---|
| SRS | Device | SRS-I |
Primary outcome
No device related serious adverse events
Time frame: up to 12 month
4 secondary outcomes
Minimal rate of device or procedure adverse events (intra and post operative Minimal rate of device or procedure adverse events (intra and post operative complications)
Time frame: up to 12 months
Improvement in POP-Q: points Aa and Ba
Time frame: up to 12 month
Improvement in POP-Q point C
Time frame: up to 12 months
Achieving normal urinary function
Time frame: up to 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 16 Aug 2019.
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Active, not recruitingObservational study
To Explore the Surgical Outcomes and Safety of an Innovative Laparoscopic Uterine Pectopexy Technique Using Inverted T-meshes for Simultaneous Apical and Anterior Vaginal Repair.
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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.
Gil Levi, Dr. principal investigator
Mayanei HaYeshua Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRS in people with Anterior Vaginal Wall Prolapse and Vaginal Apex/Uterine Prolapse, run by Lyra Medical Ltd. at 3 sites in 2 countries.
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 11 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 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Hungary. 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?
No device related serious adverse events (time frame: up to 12 month). 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 16 Aug 2019.