European registry for Senhance robotic-assisted laparoscopic surgery
The TransEnterix European Patient Registry for Robotic Assisted Laparoscopic Procedures in Urology, Abdominal Surgery, Thoracic and Gynecologic Surgery
This registry collects information about adults (18–80) who have or will have laparoscopic surgery with the Senhance robotic system to see how they do after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Asensus Surgical Industry-sponsored |
| Locations | 1 site (Siegen) |
| Trial ID | NCT03385109 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multi-center, open-label observational registry of patients treated with the Senhance Surgical System, with some sites able to enroll eligible retrospective cases. Participating centers collect baseline patient characteristics, detailed operative information, and any adverse events. Patient follow-up timing is left to routine clinical practice at each center, and only adverse events are tracked after hospital discharge. The registry is sponsored by the device manufacturer and run across participating European centers.
Who should consider this trial
Good fit: Adults aged 18–80 with life expectancy of at least 12 months who are able to sign informed consent and have had or will have a laparoscopically assisted procedure using the Senhance system are ideal candidates.
Not a fit: People under 18 or over 80, those with life expectancy under 12 months, those unable to consent, or patients having non-laparoscopic procedures are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the registry could provide real-world safety and procedure data to help patients and surgeons make more informed decisions about using the Senhance system.
How similar studies have performed: Other registries and studies of robotic-assisted laparoscopy have shown feasibility and safety in many procedures, but device-specific real-world data for the Senhance system are more limited, so this registry adds important outcomes information.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients 18-80 years old * Signed the informed consent * life expectancy 12 months or more Exclusion Criteria: \-
Where this trial is running
Siegen
- St. Marien-Krankenhaus — Siegen, Germany (Recruiting)
Study contacts
- Study coordinator: Stephanie Smith, PhD
- Email: ssmith@asensus.com
- Phone: 608-957-4850
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.