Versius Gynecology Study

CMR Surgical

Status: Enrolling

Conditions: Robotic Assisted Hysterectomy and/or Salpingo-oophorectomy

Treatments: Device: Versius Surgical System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07289295

CA-00574

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: Female

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female, aged 22 years or above, who provided written informed consent to participate in the study.
2. Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
3. Patient with BMI ≤40.

Exclusion criteria

1. Patient unwilling to provide informed consent.
2. Medical contraindication for general anaesthesia or minimally invasive procedure.
3. Oncological cases, patient undergoing surgery or treatment for malignant disease.
4. Clinically assessed Uterus size of > 14 pregnancy weeks (Estimated as > 14-15 cm longitudinal diameter).
5. Patient participation in an interventional clinical study that could impact primary outcomes results.
6. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).
7. Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Surgery with Versius

Experimental group

Treatment:

Device: Versius Surgical System