Pelvic Organ Prolapsei-StitchSSLFNCT06805006
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
An observational study of Pelvic Organ Prolapse and Genital Prolapse, run by A.M.I. Agency for Medical Innovations GmbH at 1 site in Germany.
Trial summary
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Genital Prolapse
- What is being tested?
- SSLF
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 symptomatic pelvic organ prolapse indicated for a surgical intervention.
Who may be able to join
- Surgery for POP
- SSLF with usage of i-Stitch device (\& i-Stitch Loading Units)
- Concomitant procedures are allowed
- Women minimum 18 years old
- Written informed consent for surgery
Who cannot join
- infection (active or latent)
- allergies to the materials used
- benign or malignant changes
- anticoagulation disorders
- autoimmune connective tissue disorders
- any uterus pathologies
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
Read the detailed description
The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies.
The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.
- Conditions
- Pelvic Organ Prolapse, Genital Prolapse
- Being tested
- SSLF
- Keywords
- bilateral sacrospinous ligament fixation, suture attachment medical 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.
SSLFDevice
Bilateral sacrospinous ligament fixation with i-Stitch device
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective outcome
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
Measured: 12 months
Subjective outcome
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
Measured: 3 months
Secondary outcomes (3)
Quality of life (ICIQ-UI SF)
urinary incontinence and its impact on quality of life using the short form of the International Consultation on Incontinence Questionnaire
Measured: 12 months
Postoperative complications
Complications in women undergoing bilateral SSLF using the i-Stitch
Measured: 12 months
Anatomical outcome (POP-Q)
Objective anatomical failure/recurrent prolapse in any anatomical compartment
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 posted3 Feb 2025
- Study start1 Jan 2025
- Primary completion30 Jul 2026
- Study completion31 Dec 2026 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ursula Peschers, Prof. Dr., Principal investigator, ISAR Klinikum Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805006
- Sponsor's protocol ID
- PMCF-03-011
- Acronym
- i-StitchSSLF
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
- ClinicalTrials.gov ID
- NCT06805006
- Acronym / sponsor ID
- i-StitchSSLF / PMCF-03-011
- Conditions
- Pelvic Organ Prolapse, Genital Prolapse
- Keywords
- bilateral sacrospinous ligament fixation, suture attachment medical device
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- A.M.I. Agency for Medical Innovations GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Feb 2025 (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.
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
Detailed description
The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies.
The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic pelvic organ prolapse indicated for a surgical intervention.
Key inclusion criteria (5 listed)
- Surgery for POP
- SSLF with usage of i-Stitch device (\& i-Stitch Loading Units)
- Concomitant procedures are allowed
- Women minimum 18 years old
- Written informed consent for surgery
Key exclusion criteria (6 listed)
- infection (active or latent)
- allergies to the materials used
- benign or malignant changes
- anticoagulation disorders
- autoimmune connective tissue disorders
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 |
|---|---|---|
| SSLFBilateral sacrospinous ligament fixation with i-Stitch device | Device | – |
Primary outcome
Subjective outcome
Time frame: 12 months
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
Subjective outcome
Time frame: 3 months
German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")
3 secondary outcomes
Quality of life (ICIQ-UI SF)
Time frame: 12 months
Postoperative complications
Time frame: 12 months
Anatomical outcome (POP-Q)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
Ursula Peschers, Prof. Dr. principal investigator
ISAR Klinikum Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Genital Prolapse, run by A.M.I. Agency for Medical Innovations GmbH at 1 site in Germany.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subjective outcome (time frame: 12 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 30 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.