Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2025-07-25
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgery with Versius
Versius Surgical System
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Interventions
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Versius Surgical System
Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures
Eligibility Criteria
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Inclusion Criteria
2. Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
3. Patient with BMI ≤40.
Exclusion Criteria
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.
22 Years
FEMALE
No
Sponsors
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Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
UNKNOWN
CMR Surgical Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Krzysztof Nowosielski, MD
Role: PRINCIPAL_INVESTIGATOR
Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Locations
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Uniwersyteckie Centrum Kliniczne im. prof. K. Gibińskego Śląskiego Uniwersytetu Medycznego w Katowicach
Katowice, , Poland
Countries
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Central Contacts
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Facility Contacts
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Main contact
Role: primary
Other Identifiers
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CA-00574
Identifier Type: -
Identifier Source: org_study_id