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
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Females undergoing an elective, laparoscopic total hysterectomy

• Age ≥ 18 years

• Written informed consent

Locations
Other Locations
Germany
Klinikum Sachsenhausen der DGD
RECRUITING
Frankfurt Am Main
Spain
Hospital Sant Joan de Déu de Manresa
RECRUITING
Manresa
Contact Information
Primary
Petra Baumann
petra.baumann@aesculap.de
+49746195
Time Frame
Start Date: 2024-03-19
Estimated Completion Date: 2027-01
Participants
Target number of participants: 132
Treatments
SYMMCORA®
Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic 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).
V-Loc®
Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic 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
Leads: Aesculap AG

This content was sourced from clinicaltrials.gov