Recruiting NCT07289295
Versius Gynecology Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Versius Surgical System.
- Who it may be relevant to
- Registry conditions: Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy. Basic parameters: from 22 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
Overview
The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy
Interventions
- Device Versius Surgical System
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Primary outcome measures
- Success rate [Time frame: Day of surgery]
- Serious Adverse Event rate [Time frame: Up to 30 days post procedure]
Secondary outcome measures (12)
- Operative time [Time frame: Day of surgery]
- Estimated blood loss [Time frame: Day of surgery]
- Intra-operative complications [Time frame: Day of surgery]
- Blood transfusions [Time frame: Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days]
- Unplanned instrument use [Time frame: Day of surgery]
- Device deficiencies [Time frame: Day of surgery]
- Reoperation within 24 hours [Time frame: 24 hours post-surgery]
- Length of hospital stay [Time frame: Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days]
- Adverse events [Time frame: Up to 30 days post-surgery]
- Readmission [Time frame: Up to 30 days post-surgery]
- Reoperation within 30 days [Time frame: Up to 30 days post-surgery]
- Mortality rate [Time frame: Up to 30 days post-surgery]
Eligibility criteria
Inclusion criteria
- Female, aged 22 years or above, who provided written informed consent to participate in the study.
- Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
- Patient with BMI ≤40.
Exclusion criteria
- Patient unwilling to provide informed consent.
- Medical contraindication for general anaesthesia or minimally invasive procedure.
- Oncological cases, patient undergoing surgery or treatment for malignant disease.
- Clinically assessed Uterus size of > 14 pregnancy weeks (Estimated as > 14-15 cm longitudinal diameter).
- Patient participation in an interventional clinical study that could impact primary outcomes results.
- Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).
- Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego — Katowice
Identifiers
NCT: NCT07289295 · CA-00574