Trials / Recruiting
RecruitingNCT06024109
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 132 (estimated)
- Sponsor
- Aesculap AG · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Abnormal Uterine Bleeding
- Endometriosis
- Uterine Prolapse
- Uterine Cancer
- Ovarian Cancer
- Fallopian Tube Cancer
- Cervical Cancer
- Endometrial Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2024-03-19
- Primary completion
- 2026-07-01
- Completion
- 2027-01-01
- First posted
- 2023-09-06
- Last updated
- 2025-05-13
Locations
2 sites across 2 countries: Germany, Spain
Source: ClinicalTrials.gov record NCT06024109. Inclusion in this directory is not an endorsement.