NCT06024109 Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
| NCT ID | NCT06024109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Abnormal Uterine Bleeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 132 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 132 participants in total. It began in 2024-03-19 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Females undergoing an elective, laparoscopic total hysterectomy * Age ≥ 18 years * Written informed consent Exclusion Criteria: * Emergency surgery * Open surgery * Patients undergone immunosuppressive drug treatment within the prior 6 months * Patients with hypersensitivity or allergy to the suture material. * Participation in another clinical study * Non-compliance of patient
Contact & Investigator
Amadeus Hornemann, Prof. Dr.
PRINCIPAL INVESTIGATOR
Klinikum Sachsenhausen der DGD
Frequently Asked Questions
Who can join the NCT06024109 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Abnormal Uterine Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06024109 currently recruiting?
Yes, NCT06024109 is actively recruiting participants. Contact the research team at petra.baumann@aesculap.de for enrollment information.
Where is the NCT06024109 trial being conducted?
This trial is being conducted at Frankfurt am Main, Germany, Manresa, Spain.
Who is sponsoring the NCT06024109 clinical trial?
NCT06024109 is sponsored by Aesculap AG. The principal investigator is Amadeus Hornemann, Prof. Dr. at Klinikum Sachsenhausen der DGD. The trial plans to enroll 132 participants.