Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery
NCT05433688 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150
Last updated 2026-04-13
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).
Conditions
- Adiposity
Interventions
- DEVICE
-
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).
Sponsors & Collaborators
-
B.Braun Surgical SA
collaborator INDUSTRY -
Aesculap AG
lead INDUSTRY
Principal Investigators
-
Jan H Beckmann, Dr. · University Hospital Schleswig-Holstein
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-12
- Primary Completion
- 2026-06-30
- Completion
- 2027-01-31
Countries
- Germany
Study Locations
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