NCT03385109

The TransEnterix European Patient Registry

The TransEnterix European Patient Registry for Robotic Assisted Laparoscopic Procedures in Urology, Abdominal Surgery, Thoracic and Gynecologic Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Asensus Surgical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An open label observational registry trial in which participating centers enroll subjects who had or will have a laparoscopically assisted surgery using the Senhance Surgical System.

Detailed description

This is a prospective multi-center registry in which sites may also choose to retrospectively enroll subjects meeting the inclusion criteria, but whom have already been treated using the Senhance system. The data collection includes baseline patient characteristics, surgical details, and adverse events. Patient follow-up time point is open to the clinical practice of each center and only adverse events are tracked post discharge.

Conditions

• Surgery

Interventions

Type	Name	Description
DEVICE	Surgery	Patients are approached surgically with the Senhance Surgical System

Timeline

• Start date: 2017-07-25
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2017-12-28
• Last updated: 2025-09-16

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study