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RECRUITING

NCT07832539

HYbrid RObotic Surgery in Gynecology

Sponsor: Rob Surgical Systems S.L.

View on ClinicalTrials.gov

Summary

The purpose of this clinical investigation is to evaluate the safety and performance of ROB and its corresponding ElectroSurgical Endoscopic instruments and Non-ElectroSurgical Endoscopic instruments (ESE and NESE instruments respectively) and accessories in patients with the indication of robot assisted laparoscopic Hysterectomy, Hysterectomy and Salpingectomy or Hysterectomy and Salpingectomy and Oophorectomy and when it applies Lysis of Adhesions, Lymphadenectomy and Sentinel lymph node biopsy (SLNB). HYROS-GYN is a confirmatory study in which the hypothesis of the primary endpoint is that the ESE/NESE instruments perform as intended when controlled by ROB which operates exclusively under surgeon's orders. It will include the data collected up to 30 days post-surgery.

Official title: HYbrid RObotic Surgery in Gynecology (HYROS-GYN)

Key Details

Gender

FEMALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2027-01

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Hysterectomy Hysterectomy and Salpingectomy Hysterectomy and Salpingectomy and Oophorectomy

Interventions

PROCEDURE

Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy

Hysterectomy (surgical removal of the uterus) o Hysterectomy with Bilateral Salpingectomy (surgical removal of the uterus along with the Fallopian Tubes) or Hysterectomy with bilateral Salpingectomy and Oophorectomy (Removal of the uterus along with the fallopian tubes and ovaries). In addition, as part of any of these interventions, the following procedures could be performed according to patient medical condition and/or surgeon criteria: * Lysis of abdominal lesions adhesions * Pelvic Lymphadenectomy * Sentinel Lymph node biopsy (SLN)

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

Locations (2)

Hospital Comarcal d'Inca

Inca, Balearic Islands, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain