SurgeryTRUSTNCT03385109
The TransEnterix European Patient Registry
An observational study of Surgery, run by Asensus Surgical at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery
- What is being tested?
- Surgery
- Type of treatment
- Medical device
- How many people
- 4,080 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2017to 17 Jun 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at a participating center who have had or are scheduled to have surgery using the Senhance system
Who may be able to join
- patients 18-80 years old
- Signed the informed consent
- life expectancy 12 months or more
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Surgery
- Keywords
- Robotic, Laparoscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryDevice
Patients are approached surgically with the Senhance Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Senhance Treated | All patients enrolled who go on to have a surgery in which the Senhance system is used Receives: Device: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Any untoward sign symptom or disease
Measured: Surgery to 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start25 Jul 2017
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Why it stopped: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,080 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Asensus Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385109
- Sponsor's protocol ID
- TRUST
- Acronym
- TRUST
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2017
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TransEnterix European Patient Registry for Robotic Assisted Laparoscopic Procedures in Urology, Abdominal Surgery, Thoracic and Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT03385109
- Acronym / sponsor ID
- TRUST / TRUST
- Conditions
- Surgery
- Keywords
- Robotic, Laparoscopic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.
- Enrolment
- 4,080 participants (actual)
- Lead sponsor
- Asensus SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- RQM+
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senhance Treated | – | Device: SurgeryAll patients enrolled who go on to have a surgery in which the Senhance system is used |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at a participating center who have had or are scheduled to have surgery using the Senhance system
Key inclusion criteria (3 listed)
- patients 18-80 years old
- Signed the informed consent
- life expectancy 12 months or more
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryPatients are approached surgically with the Senhance Surgical System | Device | Senhance Treated |
Primary outcome
Adverse Event
Time frame: Surgery to 30 days post op
Any untoward sign symptom or disease
Results and safety
The study was stopped early (reason given: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Asensus Surgical at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to a business decision by the acquiring company to discontinue the marketed product. The post-market surveillance registry was no longer feasible. Not related to safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (time frame: Surgery to 30 days post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.