The TransEnterix European Patient Registry (TRUST)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: Surgery

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Stephanie Smith, PhD; Phone Number: 608-957-4850; Email: ssmith@asensus.com
• Study Contact Backup: Name: Monica Marini; Phone Number: +39 342 6268232; Email: mmarini@asensus.com

Study Locations

• Germany
  • Siegen, Germany, 57072
    • Recruiting
    • St. Marien-Krankenhaus
    • Contact: Frank Willeke, MD; Phone Number: +44 0271 231 1509; Email: f.willeke@marienkrankenhaus.com
    • Principal Investigator: Dietmar Stephan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at a participating center who have had or are scheduled to have surgery using the Senhance system

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Senhance Treated; All patients enrolled who go on to have a surgery in which the Senhance system is used	Device: Surgery; Patients are approached surgically with the Senhance Surgical System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	Any untoward sign symptom or disease	Surgery to 30 days post op

Collaborators and Investigators

• Sponsor: Asensus Surgical
• Collaborators: RQM+

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic; Robotic
• Additional Relevant MeSH Terms: Surgical Procedures, Operative
• Other Study ID Numbers: TRUST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No