Hybrid robotic surgery for gynecologic procedures using ROB platform

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HYROS-GYN is a confirmatory, open-label study evaluating the safety and performance of the ROB-Bitrack robotic system and its ESE and NESE instruments during robot-assisted laparoscopic hysterectomy, with or without salpingectomy and/or oophorectomy, and with possible lymph node procedures. The study uses a single-arm, non-randomized design across two sites and follows patients from baseline through 30 days post-surgery, with visits at baseline, procedure, discharge, and days 7, 14, and 30. Adults aged 18 to 90 undergoing planned laparoscopic total hysterectomy are eligible, including those needing sentinel lymph node biopsy or pelvic lymphadenectomy per investigator criteria. The primary hypothesis centers on the safe and correct performance of the instruments when controlled by the ROB system under surgeon control. Data collection focuses on perioperative safety and device performance within 30 days of surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. \- Subjects with a gynecological indication for a laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy (i.e., removal of one or both fallopian tubes and/or ovaries).
2. \- Subjects that additionally to the hysterectomy procedure may require sentinel lymph node biopsy (SLN) and/or pelvic lymphadenectomy (LND) according to investigator criteria.
3. \- Ability and willingness to comply with all study requirements to be evaluated for each study visit

Exclusion Criteria:

1. \- Pregnant or breastfeeding women at the time of the surgery
2. \- Subjects with a medical indication for radical hysterectomy (e.g., suspected or confirmed invasive cervical cancer or other conditions requiring radical surgical management).
3. \- Subjects who had been treated with radiation therapy previous to the surgery.
4. \- Subjects with uterine enlargement \>8 cm for which morcellation would not allow for vaginal removal.
5. \- Subjects with a BMI ≥ 40
6. \- Subjects not suitable to undergo MIS/MIRS, according to medical criteria:

   1. with severe concomitant illness (e.g., severe cardiopulmonary, corornary artery disease or bleeding disorders)
   2. that have been submitted to multiple previous abdominal surgeries with multiple adhesions . 7- Subjects admitted to the hospital due to an emergency situation.

8 - Subjects with untreated active infection 9 - Subject with any contraindication for the use of Bitrack Sytem \& ESE/NESE Instruments and/or known allergy to some of the device components (i.e., stainless steel, etc.) 10 - Subjects with life expectancy inferior to 3 months 11 - Subjects with abuses of active substances or with uncontrolled psychiatric disorders 12 - Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory system or the central nervous system. 13 - Inability to adhere to study-related procedures 14 - Subjects who participate in another trial which may affect the outcome data on this study or the ability to complete the follow up requirements

Where it's running

• Hospital Universitari Vall d'Hebron
  Barcelona, Spain Recruiting
• Hospital Comarcal d'Inca
  Inca, Balearic Islands, Spain Not yet recruiting

Study contacts

• Study coordinator: Mario P Ferradosa, General Manager RSS
• Email: mario.ferradosa@robsurgical.com
• Phone: +34 930130883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.