HYbrid RObotic Surgery in Gynecology
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorRob Surgical Systems S.L.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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).
- Subjects that additionally to the hysterectomy procedure may require sentinel lymph node biopsy (SLN) and/or pelvic lymphadenectomy (LND) according to investigator criteria.
- Ability and willingness to comply with all study requirements to be evaluated for each study visit
Disqualifiers
- Pregnant or breastfeeding women at the time of the surgery
- Subjects with a medical indication for radical hysterectomy (e.g., suspected or confirmed invasive cervical cancer or other conditions requiring radical surgical management).
- Subjects who had been treated with radiation therapy previous to the surgery.
- Subjects with uterine enlargement >8 cm for which morcellation would not allow for vaginal removal.
Trial design
Design model
Single group
Treatments tested in this trial
Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy
Procedure/SurgeryHysterectomy (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)
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: Patients surgically treated with ROB Bitrack System and ESE/ NESE instruments and accessoriesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Lack of occurrence of a SAE related to the use of the medical devices under investigation during the intervention.
Evaluation of ROB Bitrack System to assist in the accurate control of its compatible ESE/NESE instruments, establishing as hypothesis that they perform as intended by the surgeon (performance score scale ≥ 3) during the intervention without causing any particular SAE related to the use of the medical devices under investigation, when devices are all used according to the respective instructions for use.
Time frame
During the procedure2
Performance
Assessment with a "Surgeon performance scale" to confirm that the ROB Bitrack System and ESE/NESE instruments perform as intended during the surgery.
Time frame
During the pocedureSponsors and contacts
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Source ClinicalTrials.gov