i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF) | NCT06805006

Studies
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

NCT06805006

Sponsor

A.M.I. Agency for Medical Innovations GmbH

Status

Enrolling by invitation

Last Update Posted

Mar 20, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pelvic Organ Prolapse
Genital Prolapse

Interventions

SSLF

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Oct 31, 2026Estimated

First Submitted Date

Jan 28, 2025

First Submission Date that Met QC Criteria

Jan 28, 2025

First Posted Date

Feb 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SSLF	Device	Bilateral sacrospinous ligament fixation with i-Stitch device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective outcome	German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")	12 months
Subjective outcome	German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")	3 months

Secondary Outcomes

Measure	Description	Time Frame
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	12 months
Postoperative complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

infection (active or latent)
allergies to the materials used
benign or malignant changes
anticoagulation disorders
autoimmune connective tissue disorders
any uterus pathologies

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with symptomatic pelvic organ prolapse indicated for a surgical intervention.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ursula Peschers, Prof. Dr.	ISAR Klinikum Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isar Kliniken GmbH		Munich	Bavaria	80331	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided