NCT06805006

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jan 2025Oct 2026

Study Start

First participant enrolled

January 1, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

January 28, 2025

Last Update Submit

March 18, 2026

Conditions

Pelvic Organ ProlapseGenital Prolapse

Keywords

bilateral sacrospinous ligament fixationsuture attachment medical device

Outcome Measures

Primary Outcomes (2)

  • Subjective outcome

    German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")

    12 months

  • Subjective outcome

    German Pelvic Floor Questionnaire ("Deutscher Beckenboden-Fragebogen")

    3 months

Secondary Outcomes (3)

  • Quality of life (ICIQ-UI SF)

    12 months

  • Postoperative complications

    12 months

  • Anatomical outcome (POP-Q)

    12 months

Interventions

SSLFDEVICE

Bilateral sacrospinous ligament fixation with i-Stitch device

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isar Kliniken GmbH

Munich, Bavaria, 80331, Germany

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ursula Peschers, Prof. Dr.

    ISAR Klinikum Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)