HysterectomyHYROS-GYNNCT07832539
HYbrid RObotic Surgery in Gynecology
A study testing Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy in people with Hysterectomy and Hysterectomy and Salpingectomy, run by Rob Surgical Systems S.L. at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Hysterectomy, Hysterectomy and Salpingectomy, Hysterectomy and Salpingectomy and Oophorectomy
- What is being tested?
- Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - 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.
- - Subjects with a BMI ≥ 40
- - Subjects not suitable to undergo MIS/MIRS, according to medical criteria:
Show all 9Show fewer
- with severe concomitant illness (e.g., severe cardiopulmonary, corornary artery disease or bleeding disorders)
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
Antonio Gil, MD Principal Study Inv., +34 934893000, rss@robsurgical.com
- Not yet recruiting
Hospital Comarcal d'Inca
Inca, Balearic Islands, 07300
Agustin Hernández Saavedra, MD Principal Investigator, +34 971 88 85 00, rss@robsurgical.com
About this study
Official title: HYbrid RObotic Surgery in Gynecology (HYROS-GYN)
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.
Read the detailed description
The ROB-Bitrack System is 4-arms on demand open and portable robotic platform indicated to be used during general abdominal laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for endoscopic visualization and manipulation of tissue. The HYROS-GYN clinical investigation will evaluate the safety and performance of ROB and its corresponding ESE and NESE Endoscopic instruments and accessories. It will include 9 patients and will be conducted in two sites, with a single arm, open-label, and non-randomized design,. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 7-Days, 14-Days and 30-Days Follow-up visits . The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy.The expected duration of the study is 6 months from the first patient enrolled to the last visit of the last patient follow up.
- Conditions
- Hysterectomy, Hysterectomy and Salpingectomy, Hysterectomy and Salpingectomy and Oophorectomy
- Being tested
- Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy
- Keywords
- Hysterectomy and Salpingectomy and Oophorectomy, Hysterectomy and Salpingectomy, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and OophorectomyProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients surgically treated with ROB Bitrack System and ESE/ NESE instruments and accessories | Experimental | Not described Receives: Procedure: Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
Performance
Assessment with a "Surgeon performance scale" to confirm that the ROB Bitrack System and ESE/NESE instruments perform as intended during the surgery.
Measured: During the pocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rob Surgical Systems S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832539
- Sponsor's protocol ID
- PL-DD-0069
- Acronym
- HYROS-GYN
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYbrid RObotic Surgery in Gynecology (HYROS-GYN)
- ClinicalTrials.gov ID
- NCT07832539
- Acronym / sponsor ID
- HYROS-GYN / PL-DD-0069
- Conditions
- Hysterectomy, Hysterectomy and Salpingectomy, Hysterectomy and Salpingectomy and Oophorectomy
- Keywords
- Hysterectomy and Salpingectomy and Oophorectomy, Hysterectomy and Salpingectomy, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Rob Surgical Systems S.L.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The ROB-Bitrack System is 4-arms on demand open and portable robotic platform indicated to be used during general abdominal laparoscopic surgical procedures. This robot is intended to assist in the accurate control of endoscopic instruments and accessories for endoscopic visualization and manipulation of tissue. The HYROS-GYN clinical investigation will evaluate the safety and performance of ROB and its corresponding ESE and NESE Endoscopic instruments and accessories. It will include 9 patients and will be conducted in two sites, with a single arm, open-label, and non-randomized design,. The planned visits for this clinical investigation are baseline (includes Screening, baseline visit, and Informed consent), procedure, discharge, 7-Days, 14-Days and 30-Days Follow-up visits . The clinical investigation will include adult subjects (between 18 and 90 years old) who have been scheduled for laparoscopic total hysterectomy, with or without salpingectomy and/or oophorectomy.The expected duration of the study is 6 months from the first patient enrolled to the last visit of the last patient follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients surgically treated with ROB Bitrack System and ESE/ NESE instruments and accessories | Experimental | Procedure: Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (9 listed)
- - 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.
- - Subjects with a BMI ≥ 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and OophorectomyHysterectomy (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) | Procedure or surgery | Patients surgically treated with ROB Bitrack System and ESE/ NESE instruments and accessories |
Primary outcome
Lack of occurrence of a SAE related to the use of the medical devices under investigation during the intervention.
Time frame: During the procedure
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.
Performance
Time frame: During the pocedure
Assessment with a "Surgeon performance scale" to confirm that the ROB Bitrack System and ESE/NESE instruments perform as intended during the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysterectomy or Hysterectomy with Bilateral Salpingectomy or Hysterectomy with bilateral Salpingectomy and Oophorectomy in people with Hysterectomy and Hysterectomy and Salpingectomy, run by Rob Surgical Systems S.L. at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario P Ferradosa, General Manager RSS (+34 930130883, mario.ferradosa@robsurgical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lack of occurrence of a SAE related to the use of the medical devices under investigation during the intervention. (time frame: During the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.