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Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy

NCT06024109 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 132

Last updated 2025-05-13

No results posted yet for this study

Summary

The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate.

Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. Both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be applied in their intended use. Neither additional invasive measures nor additional burden in regard to the patient will be performed.

Conditions

Interventions

DEVICE

Closure of the Vaginal Cuff after Total Hysterectomy

Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Principal Investigators

  • Amadeus Hornemann, Prof. Dr. · Klinikum Sachsenhausen der DGD

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-19
Primary Completion
2026-07-31
Completion
2027-01-31

Countries

  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT06024109 on ClinicalTrials.gov