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Comparison of Three Robotic Platforms for Hysterectomy

NCT06138197 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-03-04

No results posted yet for this study

Summary

Hysterectomy is the most common procedure in gynaecology after a cesarean section. In recent years, the laparoscopic approach has become preferred given the different advantages over the traditional laparotomic approach, and both conventional laparoscopy and robotic-assisted laparoscopy have become the standard approach for hysterectomy. To date, robotic-assisted laparoscopic hysterectomy has been performed using one robotic platform and only recently, two new robotic platforms have been introduced in clinical practice. Although all three are registered for human use and available for clinical practice, there are currently not enough clinical experiences and data in the literature to evaluate the efficacy, safety and relationship between cost and efficacy of the new platforms available for the robotic-assisted laparoscopic hysterectomy. For this reason, the investigators will conduct an exploratory clinical study on a Post Market Clinical Follow up (PMCF) medical device aimed at performing a preliminary assessment of the global performance of the ITL procedure implemented using the three robotic platforms currently available.

Conditions

  • Hysterectomy

Interventions

PROCEDURE

Robotic-assisted hysterectomy

Robotic-assisted hysterectomy following usual surgical technique

Sponsors & Collaborators

  • Universita di Verona

    lead OTHER

Principal Investigators

  • Stefano Uccella, MD, PhD · Universita di Verona

  • Simone Garzon, MD · Universita di Verona

  • Pier Carlo Zorzato, MD · Universita di Verona

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06138197 on ClinicalTrials.gov