The TransEnterix European Patient Registry

Surgery Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385109
• Other study ID #: TRUST
• Status: Recruiting
• Start date: July 25, 2017
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2019
• Source: TransEnterix
• Contact: Stephanie Fitts
• Phone: 919-765-8430
• Email: sfitts[@]transenterix.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients 18-80 years old

• Signed the informed consent

• life expectancy 12 months or more

Exclusion Criteria:

Related Conditions & MeSH terms

• Surgery

Intervention

Device:
• Surgery
Patients are approached surgically with the Senhance Surgical System

Locations

Country	Name	City	State
Germany	St. Marien-Krankenhaus	Siegen

Sponsors (3)

Lead Sponsor	Collaborator
TransEnterix	CRO De. med Kottmann GmbH & Co, St. Marien-Krankenhays Siegen gem. GmbH Department of Surgery

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event	Any untoward sign symptom or disease	Surgery to 30 days post op