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Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair

NCT03821142 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-11-22

No results posted yet for this study

Summary

Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Transvaginal mesh for anterior pelvic organ prolapse repair

synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population

Sponsors & Collaborators

  • Promedon

    lead INDUSTRY

Principal Investigators

  • Gert Naumann, PD Dr.habil. · Helios Hospital Erfurt

  • Ralf Tunn, Prof.Dr. · St. Hedwig Hospital

  • Dirk Watermann, Prof.Dr. · Evangelic Diakonie Hospital

  • Birgit Henne, Dr.med. · St. Elisabeth-Hospital Leipzig

  • Christl Reisenauer, Prof.Dr.med. · University Hospital Tübingen

  • Christian Fünfgeld, Dr.med. · Hospital Tettnang

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2026-10-31
Completion
2029-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03821142 on ClinicalTrials.gov