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Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
Sponsor: Aesculap AG
Summary
The study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (Symmcora® mid term, UBS) vs. a conventional suture (Novosyn®, CS). Patient will be randomly allocated in a 1:1 ratio to either the UBS group or the CS group to perform the gastro-jejunal anastomosis (GJA) and the jejuno-jejunal anastomosis (JJA). The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
Official title: Prospective, Mono-center, Randomized, Single-blinded, Controlled Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2022-10-12
Completion Date
2027-01
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Robotic assisted gastric bypass surgery
The product under investigation and the conventional suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
Locations (1)
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany