The TransEnterix European Patient Registry

Recruiting

• Conditions: Surgery
• Interventions: Device: Surgery

• Registration Number: NCT03385109
• Lead Sponsor: TransEnterix

Brief 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.

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients 18-80 years old
• Signed the informed consent
• life expectancy 12 months or more

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Senhance Treated	Surgery	All patients enrolled who go on to have a surgery in which the Senhance system is used

Primary Outcome Measures

Name	Time	Method
Adverse Event	Surgery to 30 days post op	Any untoward sign symptom or disease

Trial Locations

Locations (1)

St. Marien-Krankenhaus; 🇩🇪 Siegen, Germany