Intra-operative ComplicationsPhase 2/3NCT01909700
Single Incision Pelvic Floor Mesh Implants
A Phase 2/3 study testing Single Incision Mesh in people with Intra-operative Complications and Post Operative Complications, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse. Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intra-operative Complications, Post Operative Complications
- What is being tested?
- Single Incision Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Feb 2012
- Phase
- Phase 2/3
- 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 30 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Gr 2-3 Pelvic Organ Prolapse
Who cannot join
- Previous Pelvic irradiation
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse.
Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure.
Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.
Read the detailed description
Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates
- Being tested
- Single Incision Mesh
- Keywords
- Single Incision, Mesh, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Incision MeshDevice
Single Incision Mesh is implanted for pelvic floor reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Single Incision Mesh | Experimental | intervention: single incision mesh implantation Receives: Device: Single Incision Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative mesh related complications
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 posted26 Jul 2013 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-operative ComplicationsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Menahem Neuman, Prof., Principal investigator, Western Galilee MC Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909700
- Sponsor's protocol ID
- 2011041
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Pelvic Floor Mesh Implants
- ClinicalTrials.gov ID
- NCT01909700
- Acronym / sponsor ID
- 2011041
- Keywords
- Single Incision, Mesh, Complications
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Jul 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.
Objectives: To evaluate whether the use of single incision un-anchored small mesh implants is feasible, safe and effective for women with moderate pelvic organ prolapse.
Design: Patients diagnosed with moderate pelvic organ prolapse were enrolled to undergo a single incision un-anchored mesh operation. Follow-up was 4 to 23 months. The outcome measures for this study were the operative safety and post-operative pain, adverse effects and anatomical as well as functional cure.
Setting: The operations were performed under general anesthesia according with the reported surgical techniques at university and private hospitals.
Detailed description
Eligibility criteria: female patients with moderate pelvic organ prolapse Outcome measures: intra operative safety and surgical complications, post operative complications and objective as well as subjective cure rates
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Incision Mesh | Experimental | Device: Single Incision Meshintervention: single incision mesh implantation |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Gr 2-3 Pelvic Organ Prolapse
Key exclusion criteria (1 listed)
- Previous Pelvic irradiation
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 |
|---|---|---|
| Single Incision MeshSingle Incision Mesh is implanted for pelvic floor reconstruction | Device | Single Incision Mesh |
Primary outcome
Operative mesh related complications
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 5 May 2016.
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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.
Menahem Neuman, Prof. principal investigator
Western Galilee MC Nahariya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Single Incision Mesh in people with Intra-operative Complications and Post Operative Complications, run by Western Galilee Hospital-Nahariya at 1 site 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 1 inclusion and 1 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 5 May 2016. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Operative mesh related complications (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 5 May 2016.