NCT05433688

Study on the Performance of Symmcora® Mid-term Suture Versus Novosyn® Suture in Patients Undergoing Robotic Assisted Gastric Bypass Surgery

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2022-10-12
• Primary completion: 2026-06-01
• Completion: 2027-01-01
• First posted: 2022-06-27
• Last updated: 2026-04-13

Locations

1 site across 1 country: Germany