The avatera registry for observing the avatera system in use for urological and gynaecological surgery across 10 European clinical centres

The avatera registry for the post-market clinical follow-up, non-interventional observation of using the avatera system in robot-assisted urological and gynaecological surgery across 10 European clinical centres

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN45854742

Enrollment

1000

Registered

2022-07-28

Start date

2022-06-01

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Robot-assisted surgery with the avatera system in urology and gynaecology Surgery

Interventions

The source data of the intended registry is the observation of the clinical application of the Avatera robotic system. Patients who agreed to participate in the observation will be accompanied by docu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients eligible for minimally invasive surgery in urology or gynaecology

Exclusion criteria

Exclusion criteria: Patients not eligible for minimally invasive surgery in urology or gynecology

Design outcomes

Primary

Measure	Time frame
Conversion rate of the robot-assisted surgery to an alternative surgical method on the day of surgery, calculated as the number of patients who required conversion to an alternative surgical method (manual laparoscopic or open surgery) under surgery divided by the number of all patients who underwent surgery. The basis for the calculation is the total population.	—

Secondary

Measure	Time frame
1. Perioperative complications: the frequencies of the observed complication categories are presented per visit resp. interview and sorted by descending frequency on the day of surgery, daily postoperative visit until release visit, postoperative interview on day 30 and day 90 2. Perioperative process times measured using timetracking by any clock in the operating theatre at preparation time of the system, docking, cut-to-suture time, console time and undocking 3. Estimated intraoperative blood loss measured by estimation of suction liquid volume minus any rinsing volume at postoperative 4. Intraoperative blood transfusions, including their number, counted at postoperative 5. Duration of the inpatient stay, measured as the period from the day of admission until the day of release, at the release visit 6. Patient-related outcomes: pain assessment and activity status measured using interview and patient’s assessment on the Verbal Rating Scale and the ECOG/WHO activity score at the admission visit, daily postoperative visit until release visit, and postoperative interview on day 30 and day 90	—

Measure

Time frame

1. Perioperative complications: the frequencies of the observed complication categories are presented per visit resp. interview and sorted by descending frequency on the day of surgery, daily postoperative visit until release visit, postoperative interview on day 30 and day 90 2. Perioperative process times measured using timetracking by any clock in the operating theatre at preparation time of the system, docking, cut-to-suture time, console time and undocking 3. Estimated intraoperative blood loss measured by estimation of suction liquid volume minus any rinsing volume at postoperative 4. Intraoperative blood transfusions, including their number, counted at postoperative 5. Duration of the inpatient stay, measured as the period from the day of admission until the day of release, at the release visit 6. Patient-related outcomes: pain assessment and activity status measured using interview and patient’s assessment on the Verbal Rating Scale and the ECOG/WHO activity score at the admission visit, daily postoperative visit until release visit, and postoperative interview on day 30 and day 90

—

Countries

Germany, Greece, Hungary

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026