Pelvic Organ ProlapseNCT02190825
Safety and Efficacy Study of the NeuGuide Device
A study testing NeuGuide device in people with Pelvic Organ Prolapse, run by Pop Medical Solutions at 2 sites in Israel.
Trial summary
This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP). Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- NeuGuide device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2014to 30 Oct 2023
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 18-80 years old
- POP-Q stage III prolapse or higher
- Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM device
- Patient is willing to return for follow-up evaluation and fill questionnaires as indicated on study protocol
- No exclusion criteria fulfilled
Who cannot join
- Diagnosis of reproductive tract anomalies
- Prior pelvic radiation therapy or any malignancy
- Inability to complete written questionnaires.
- Women with significant Pelvic Inflammatory Disease (PID) history
- Women with known allergy to Nickel or Nitinol
Trial locations and contacts
2 sites in 1 country.
About this study
This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP).
Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system.
Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel
- Conditions
- Pelvic Organ Prolapse
- Being tested
- NeuGuide device
- 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.
NeuGuide deviceDevice
The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of pelvic floor prolapse as defined by POP-Q score
Measured: 6 months
Complications (SAE, AE)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2016
- Study completion30 Oct 2023
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pop Medical Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190825
- Sponsor's protocol ID
- CD0040
- Status last verified
- Nov 2023
- First submitted
- 9 Jul 2014
- Last updated
- 22 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of the NeuGuide Device
- ClinicalTrials.gov ID
- NCT02190825
- Acronym / sponsor ID
- CD0040
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pop Medical SolutionsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 15 Jul 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.
This study aims to investigate the safety, efficacy, peri and postoperative complications, and patient satisfaction of sacro-spinous ligament fixation (SSLF) for the management of pelvic organ prolapse (POP).
Prolapse staging for all subjects in this study will be performed according to the POP-Q staging system.
Ultrasound examinations for all subjects in this study are subjected to the surgeon need and will be performed if required by qualified personnel
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women ages 18-80 years old
- POP-Q stage III prolapse or higher
- Scheduled to undergo a POP Surgery and has agreed to undergo it using the NeuGuideTM device
- Patient is willing to return for follow-up evaluation and fill questionnaires as indicated on study protocol
- No exclusion criteria fulfilled
Key exclusion criteria (5 listed)
- Diagnosis of reproductive tract anomalies
- Prior pelvic radiation therapy or any malignancy
- Inability to complete written questionnaires.
- Women with significant Pelvic Inflammatory Disease (PID) history
- Women with known allergy to Nickel or Nitinol
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 |
|---|---|---|
| NeuGuide deviceThe NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor | Device | – |
Primary outcome
Stage of pelvic floor prolapse as defined by POP-Q score
Time frame: 6 months
Complications (SAE, AE)
Time frame: Up to 6 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 22 Nov 2023.
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
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Active, not recruitingObservational study
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Pelvic Floor Muscle Training During Pregnancy
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Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuGuide device in people with Pelvic Organ Prolapse, run by Pop Medical Solutions at 2 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 5 inclusion and 5 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Stage of pelvic floor prolapse as defined by POP-Q score (time frame: 6 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 22 Nov 2023.