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The TransEnterix European Patient Registry (TRUST)

A

Asensus Surgical

Status

Enrolling

Conditions

Surgery

Treatments

Device: Surgery

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-

Trial design

500 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Stephanie Smith, PhD; Monica Marini

Data sourced from clinicaltrials.gov

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