Anterior Vaginal Wall Prolapse With/Without Apical/Uterine DescentNCT03195361
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
A study testing SRS - Self Retaining Support system in people with Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent, run by Lyra Medical Ltd. at 3 sites in Israel.
Trial summary
A prospective, single arm, 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 50 to 75 years, women only
- Conditions the study is for
- Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
- What is being tested?
- SRS - Self Retaining Support system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesIsrael
- Study dates
- Mar 2016to 20 Dec 2020
- 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 50 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 50 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Who cannot join
- Patient is pregnant or breastfeeding
- Patient is suffering from active infection (on antibiotic therapy)
- Patient is planning vaginal delivery
- Patient had previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory 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.
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- Malignancy.
- Known hypersensitivity to PEEK and/or polypropylene materials.
- Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
- Diagnosed with mental or emotional disturbance.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Mayanei HaYeshua Medical Center
Bnei Brak, 51544
Ziv Medical center
Safed
Asaf HaRofeh Medical Center
Zrifin, 70300
About this study
A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
Read the detailed description
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
- Being tested
- SRS - Self Retaining Support system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRS - Self Retaining Support systemDevice
Also called transvaginal surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | Subjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device Receives: Device: SRS - Self Retaining Support system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in POP-Q points Aa and Ba
Points Aa and\or Ba are less than -1
Measured: 36 months
Improvement in POP-Q point C:
Point C at -5 or less
Measured: 36 months
No unexpected serious adverse device related events
Measured: 36 months
Secondary outcomes (2)
Achieving normal urinary function:
Patient does not experience voiding dysfunction and have negative Urinary Cough Test.
Measured: 36 Months
Improvement in Quality Of Life (QoL)
Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12.
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study startMar 2016
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Vaginal Wall Prolapse With/Without Apical/Uterine DescentStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lyra Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195361
- Sponsor's protocol ID
- CD-14-011
- Status last verified
- Jan 2021
- First submitted
- 1 May 2016
- Last updated
- 3 Feb 2021
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT03195361
- Acronym / sponsor ID
- CD-14-011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lyra Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 22 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.
A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
Detailed description
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Device: SRS - Self Retaining Support systemSubjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device |
Who may qualify
- Ages
- 50 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 50 and 75 years old
- POP-Q: Aa and/or Ba is at least -1
Key exclusion criteria (10 listed)
- Patient is pregnant or breastfeeding
- Patient is suffering from active infection (on antibiotic therapy)
- Patient is planning vaginal delivery
- Patient had previous vaginal mesh surgery
- Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory 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 - Self Retaining Support systemAlso: transvaginal surgical treatment | Device | Single-arm |
Primary outcome
Improvement in POP-Q points Aa and Ba
Time frame: 36 months
Points Aa and\or Ba are less than -1
Improvement in POP-Q point C:
Time frame: 36 months
Point C at -5 or less
No unexpected serious adverse device related events
Time frame: 36 months
2 secondary outcomes
Achieving normal urinary function:
Time frame: 36 Months
Improvement in Quality Of Life (QoL)
Time frame: 36 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 3 Feb 2021.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRS - Self Retaining Support system in people with Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent, run by Lyra Medical Ltd. at 3 sites in Israel.
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 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 3 Feb 2021. 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. 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?
Improvement in POP-Q points Aa and Ba (time frame: 36 months). The study lists 3 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 3 Feb 2021.