The avatera registry for observing the avatera system in use for urological and gynaecological surgery across 10 European clinical centres
| ISRCTN | ISRCTN45854742 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45854742 |
- Submission date
- 10/06/2022
- Registration date
- 28/07/2022
- Last edited
- 24/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
The avatera robotic system supports surgeons in “keyhole” minimally invasive surgery in urology and gynecology. The manufacturer of this system, avateramedical GmbH - Jena, Germany - is legally required to monitor the clinical application of this medical device in a post-market clinical follow-up. The clinical performance of the avatera system is observed and the observation is documented in order to ascertain its safe and efficient usage. This observation takes place in 10 clinical centres across Europe recording successful completion of the surgical intervention with the avatera system and recovery of 1000 patients. The avatera registry will collect and analyse all observations into one dataset. This overview will allow avateramedical to spot sufficiencies and deficiencies of the avatera system in order to establish and maintain a safe medical device.
Who can participate?
patients who are eligible for minimally invasive urological or gynecological surgery
What does the study involve?
Clinical centres participating in the avatera observation will ask patients who are eligible for minimally invasive urological or gynecological surgery at the surgeon’s discretion to consent to documentation and analysis of data related to the patient’s disease and recovery.
What are the possible benefits and risks of participating?
In combination with technical data of the avatera system, avateramedical will obtain important feedback on the safe and efficient performance of its avatera system.
Where is the study run from?
avateramedical GmbH (Germany)
When is the study starting and how long is it expected to run for?
January 2021 to September 2024
Who is funding the study?
avateramedical GmbH (Germany)
Who is the main contact?
Dr Elke Grunow
ava-PMCF-registry@avateramedical.com
Contact information
Scientific
avateramedical GmbH
Ernst-Ruska-Ring 23
Jena
07745
Germany
| Phone | +49 (0)3641 2724 163 |
|---|---|
| ava-PMCF-registry@avateramedical.com |
Scientific
avateramedical GmbH
Ernst-Ruska-Ring 23
Jena
07745
Germany
| Phone | +49 (0)151 72433145 |
|---|---|
| ava-PMCF-registry@avateramedical.com |
Study information
| Study design | Prospective non-interventional observational multicentric registry |
|---|---|
| Primary study design | Observational |
| Secondary study design | Registry |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | 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 |
| Study objectives | The avatera registry summarizes the non-interventional observation of the avatera system in routine clinical practice across 10 European clinical centres with no issue in research. The aim of this post-market clinical follow-up observation is to collect evidence of the safety and effectiveness of this surgical robotic system |
| Ethics approval(s) | The avatera registry serves as a database collecting evidence from participating clinical centres. It therefore does not require ethics approval. The documentation of the observation in the clinical centres engaged is presented to the national local ethics committee in charge, respectively. |
| Health condition(s) or problem(s) studied | Robot-assisted surgery with the avatera system in urology and gynaecology |
| Intervention | 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 documentation from their admission visit to their release visit and 30- and 90-day postoperative telephone interviews, to document and describe: 1. Their diagnoses to be treated minimally invasive 2. Their health status (ASA scores, pain assessment score, activity score) 3. Successful surgery with the Avatera system or necessity to interrupt/abort/convert to another surgical method 4. Any surgical or technical complications |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 11/01/2021 |
| Completion date | 30/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 patients per clinical centre |
| Key inclusion criteria | Patients eligible for minimally invasive surgery in urology or gynaecology |
| Key exclusion criteria | Patients not eligible for minimally invasive surgery in urology or gynecology |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 01/12/2023 |
Locations
Countries of recruitment
- Germany
- Greece
- Hungary
Study participating centres
26504 Pio
Patras
26504
Greece
Lange-Feld-Straße 31
Hannover
30559
Germany
Ratzeburger Allee 160
Lübeck
23562
Germany
Köves u. 1
Budapest
1204
Hungary
Sponsor information
Industry
Ernst-Ruska-Ring 23
Germany
Jena
07745
Germany
| Phone | +49 (0)3641 2724 0 |
|---|---|
| info@avateramedical.com | |
| Website | https://www.avatera.eu/home |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The avatera registry discloses the observation, documentation and summary of the avatera system post-market clinical follow-up. It is the aim and wish of participating investigators and the sponsor to share experiences with the interested public and scientific auditory. |
| IPD sharing plan | The datasets generated and analysed during the current study will be stored in a non-publically available repository. The data repository is a database provided by the Clinical Research Organization GWT-TUD GmbH, Dresden, Germany. The database is run by the system secuTrial, hosted by interactiveSystems (iAS), Berlin, Germany. Data management is solely owned by the CRO. All participants of the avatera PMCF-observation have been informed of the purpose of this observational investigation and succeeding summary of all participating centres in a registry. Participants could only be included after written consent, which explicitly covers the allowance to use pseudonymised person-related data. |
Editorial Notes
24/02/2023: Contact details updated.
10/02/2023: Contact details updated.
22/06/2022: Trial's existence confirmed by Vinzenzkrankenhaus Hannover GmbH.
