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Prostate CancerGTSPNCT07792109

Implementation Of A Telesurgery Program At A Referral Center For Robotic Surgery

A study testing Robot-Assisted Telesurgery in people with Prostate Cancer and Colorectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This prospective, single-center pilot cohort study aims to evaluate the feasibility and safety of implementing a robotic telesurgery program in a tertiary academic referral center. Adult patients scheduled for elective robotic procedures, like radical prostatectomy or colectomy . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer, Colorectal Cancer
What is being tested?
Robot-Assisted Telesurgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesItaly
Study dates
20 Aug 2026to 30 May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • No significant comorbidities according to the Charlson Comorbidity Index.
  • No history of major abdominal surgery.
  • Scheduled for elective robot-assisted surgery.
  • Able to understand the study procedures and provide written informed consent.

Who cannot join

  • Severe comorbidities that may interfere with study participation or surgical safety.
  • Severe bleeding or coagulation disorders, or ongoing treatments that significantly affect coagulation.
  • Inability to understand the study procedures or provide informed consent.
  • Unwillingness or inability to comply with the study protocol.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Italy3 sites
  • Unita Operativa Complessa - Urologia - Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168

    Maria Chiara MC sighinolfi, md, phD, +393291329216, mariachiara.sighinolfi@policlinicogemelli.it

    Maria Chiara Sighinolfi

  • Unita Operativa Complessa di Ginecologia Oncologica e UOC Carcinoma Ovarico, IRCCS Gemelli

    Rome, Roma, 00168

    Anna Fagotti

    Anna Fagotti

  • Unita Oprativa Complessa Chirurgia Generale - IRCCS Fondazione Policlinico Gemelli , Roma

    Rome, Roma, 00168

    Sergio Alfieri

    Sergio Alfieri

Other trials in Italy

About this study

Official title: Implementation Of A Telesurgery Program At A Referral Center For Robotic Surgery: Feasibility And Safety Evaluation - Gemelli TeleSurgery Program (GTSP)

This prospective, single-center pilot cohort study aims to evaluate the feasibility and safety of implementing a robotic telesurgery program in a tertiary academic referral center. Adult patients scheduled for elective robotic procedures, like radical prostatectomy or colectomy . Surgical procedures will be performed using the Toumai robotic surgical system. During predefined operative steps, a remote console surgeon located at Gemelli Isola Hospital will perform selected surgical tasks, while the primary console surgeon, the patient, and the entire operating room team remain at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The local surgeon can immediately resume control of the robotic system whenever required. First objective is to assess the feasibility and safety of telesurgery by evaluating the rate of conversion from remote to local robotic surgery. Other objectives include assessment of network performance, technical reliability, perioperative outcomes, and user and patient satisfaction.

Read the detailed description

Telesurgery is an emerging application of robotic-assisted surgery that enables surgeons to perform selected operative tasks remotely through advanced robotic systems and secure telecommunication technologies. Recent advances in robotic platforms, high-speed network infrastructures, and low-latency connectivity have renewed interest in the clinical implementation of telesurgery. Nevertheless, its adoption in routine clinical practice remains limited because further evidence regarding technical feasibility, safety, organizational requirements, and reproducibility is needed.

Consecutive adult patients eligible for robot-assisted procedures will be enrolled over a three-month recruitment period.

All procedures will be performed at Fondazione Policlinico Universitario Agostino Gemelli IRCCS using the Toumai robotic surgical platform. The patient, bedside surgical team, and primary console surgeon will remain at the Gemelli Hospital throughout the procedure. During predefined surgical phases, a second console surgeon located at Gemelli Isola Hospital will remotely perform selected operative steps. A dedicated network infrastructure with redundant dark-fiber connections, encrypted communication, and predefined latency thresholds has been implemented to ensure secure and reliable data transmission. Whenever considered necessary because of technical issues or surgical judgment, the local console surgeon can immediately resume direct control of the robotic system according to predefined safety protocols.

The primary endpoint is the conversion rate from remote telesurgical control to local robotic surgery during the telesurgical phases of the operation. Secondary endpoints include assessment of technical performance, network latency and reliability, intraoperative and postoperative outcomes, device-related malfunctions, and user and patient satisfaction. The study is intended to generate clinical and organizational evidence supporting the safe implementation of robotic telesurgery in routine surgical practice.

Being tested
Robot-Assisted Telesurgery
Keywords
Robotic Surgery, Remote Surgery, Prostatectomy, Colectomy, Prostate Cancer, Colorectal Cancer, Feasibility
Medical subject headings
Prostatic Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robot-Assisted TelesurgeryDevice

    Robot-assisted telesurgery performed using the Toumai robotic surgical system. Patients undergo robotic surgery at Fondazione Policlinico Gemelli IRCCS. The surgical procedure is initiated and completed by the local surgical team, while one or more predefined surgical steps are performed remotely by a second console surgeon located at Isola Tiberina Hospital. At any time during the procedure, the local console surgeon can immediately resume control of the robotic system if required.

Study groups in NCT07792109
Study groupRoleWhat they receive
Patients Undergoing Robotic Surgery With Remote Surgical SupportExperimentalPatients undergoing robot-assisted telesurgery, with the operating surgeon located at a remote hospital site while the patient undergoes the procedure at the referral center.
Receives: Device: Robot-Assisted Telesurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Conversion Rate from Remote to Local Robotic Surgery (%)

    Rate (%) of conversion from remote robotic surgery to completion of the procedure by the local console surgeon without further remote surgical involvement (due to unintended/urgent/emergency issues)

    Measured: Intraoperatively

Secondary outcomes (5)
  1. Rate of Intraoperative Adverse Events

    Occurrence and severity of intraoperative adverse events graded according to the Satava grading system and ICARUS classification.

    Measured: Intraoperatively

  2. Postoperative Complications

    Postoperative complications graded according to the Clavien-Dindo classification.

    Measured: Up to 30 post-operative days

  3. Network Latency (msec)

    Mean network latency recorded during the entire surgical procedure and during each surgical step.

    Measured: Intraoperatively

  4. Rate of Technical Malfunctions

    Number and type of technical malfunctions, including alarms, collisions, and deviations from the planned surgical strategy.

    Measured: Intraoperatively

  5. Length of Hospital Stay (day)

    Length of postoperative hospital stay.

    Measured: Time (days) up to hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2026
  2. Study start20 Aug 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm prospective interventional study evaluating the feasibility and safety of a telesurgery program during robot-assisted surgical procedures performed at a tertiary referral center.
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07792109
Sponsor's protocol ID
7727
Acronym
GTSP
Status last verified
Aug 2026
First submitted
5 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reitano G, Tumminello A, Ghaffar U, Saggionetto G, Taverna A, Mangiacavallo F, Ahmed ME, Basourakos SP, Carletti F, Minardi D, Iafrate M, Morlacco A, Betto G, Karnes RJ, Moro FD, Zattoni F, Novara G. Perioperative, Oncological, and Functional Outcomes of New Multiport Robotic Platforms in Urology: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2025 Mar 3;74:44-70. doi: 10.1016/j.euros.2025.02.003. eCollection 2025 Apr.

    PubMed 40115596
  • Pokhrel G, Zheng H, Tao J, Cui J, Fan Y, Li Z, Dong B, Yu S, Zhang X. Assessing the Feasibility and Safety of the Toumai(R) Robotic System in Urologic Surgery: Initial Experience. J Endourol. 2024 Jun;38(6):552-558. doi: 10.1089/end.2024.0028.

    PubMed 38468506
  • Pokhrel G, Zheng H, Tao J, Fan Y, Liu Y, Dong B, Yu S, Zhang X. Evaluation of the Toumai robotic system in partial nephrectomy and key system features. Sci Rep. 2025 Apr 16;15(1):13046. doi: 10.1038/s41598-025-97124-x.

    PubMed 40240465
  • Rocco B, Patel V, Covas Moschovas M, Gaia G, Sighinolfi MC. Pre-clinical evaluation of telesurgery with the Toumai microport: the standpoint from multiplatform users. Minerva Urol Nephrol. 2024 Dec;76(6):671-673. doi: 10.23736/S2724-6051.24.06091-9. No abstract available.

    PubMed 39831852
  • Patel V, Collins JW, Marescaux J, Dohler M, Saikali S, Dasgupta P, Reddy S, Gamal A, Patel E, Rogers T, Siddiqui A, Breda A, Mottrie A, Hassan A, Hung A, Secord A, Rocco B, Pugh C, Sundaram C, Sighinolfi MC, Ellison EC, Davila EP, Wilson E, Balkhy H, Kaouk J, Liang C, Kavoussi LR, Roche M, Martino M, Anvari M, Sylla P, Coelho RF, Thomas R, Clayman R, Leveillee R, Estape R, Goldberg R, Madder R, Horgan S, Magnuson JS, Nathan S, Ross S, Costello A, Xu Z, Chauhan S, Redan J, Satava R, Miles B, Sachdeva AK, Moschovas MC. International multispecialty consensus statement and expert opinion of best practices in telesurgery. J Robot Surg. 2025 Apr 1;19(1):135. doi: 10.1007/s11701-025-02298-1. No abstract available.

    PubMed 40167848
  • Wu S, Wu N, Wang Y, Jing R, Wu Y, Yi S. 5G remote robotic-assisted transcervical thyroidectomy: the first case report in the world. BMC Surg. 2025 Apr 25;25(1):182. doi: 10.1186/s12893-025-02927-4.

    PubMed 40281540
  • Ferreira SV, Sugai MH, Nascimento GC, Souza AC Netto, Cabrini GC, Rodrigues FM, D'Avila CLR, Souza GF, Zerati RV, Zerati M Filho. Feasibility and Initial Outcomes of Telesurgery in Urology: a Systematic Review of the Literature. Int Braz J Urol. 2025 May-Jun;51(3):e20240494. doi: 10.1590/S1677-5538.IBJU.2024.0494.

    PubMed 40079922
  • Tian Y, Lv H, Jumai A, Tuerhong T, Zhuang L, Huang J, Li J, Lu P, Tao G, Yamauchi Y, Flores RM, Teng H, Chen T, Luo Q. Ultra-remote robot-assisted right upper lobectomy between the Shanghai and Kashi Prefectures: a case report. J Thorac Dis. 2024 Dec 31;16(12):8823-8830. doi: 10.21037/jtd-24-1605. Epub 2024 Dec 27.

    PubMed 39831214
  • Aldousari S, Almarzouq A, Hassan A, Shahin A, Bubishate S, Bahbahani B. The era of telesurgery: insights from ultra-long-distance Asia to Middle East human telesurgery robotic assisted radical prostatectomy. J Robot Surg. 2025 Mar 11;19(1):108. doi: 10.1007/s11701-025-02274-9.

    PubMed 40064737
  • Rocco B, Moschovas MC, Saikali S, Gaia G, Patel V, Sighinolfi MC. Insights from telesurgery expert conference on recent clinical experience and current status of remote surgery. J Robot Surg. 2024 Jun 4;18(1):240. doi: 10.1007/s11701-024-01984-w.

    PubMed 38833111
  • Moschovas MC, Dohler M, Patel V. Telesurgery: Challenges, Ethical Considerations, and Opportunities in the Robotic Surgery Era. Eur Urol Focus. 2025 Jan;11(1):40-42. doi: 10.1016/j.euf.2025.02.016. Epub 2025 Mar 3.

    PubMed 40037973
  • Moschovas MC, Saikali S, Dohler M, Patel E, Rogers T, Gamal A, Marquinez J, Patel V. Advancing Telesurgery Connectivity Between North and South America: the first Remote Surgery Conducted Between Orlando and Sao Paulo in Animal Models. Int Braz J Urol. 2025 Jan-Feb;51(1):e20240601. doi: 10.1590/S1677-5538.IBJU.2024.0601. No abstract available.

    PubMed 39556854
  • Moschovas MC, Palmer K, Barani G, Corder C, Carnegie P, Dhanji T, Patel E, Paxi A, Figueiredo JC, Luis B, Matos A, Dohler M, Patel V. Expanding access to high-quality surgical care in Africa: a landmark achievement in telesurgery. J Robot Surg. 2025 Mar 24;19(1):124. doi: 10.1007/s11701-025-02292-7.

    PubMed 40128381
  • Moschovas MC, Saikali S, Rogers T, Dohler M, Mcdonald M, Patel E, Marquinez J, Gamal A, Magnuson J, Patel V. Exploring the Teleproctoring Potential of Telesurgery: The First Remote Procedures Performed Simultaneously Between Orlando and Shanghai. Int Braz J Urol. 2025 Jul-Aug;51(4):e20250083. doi: 10.1590/S1677-5538.IBJU.2025.0083.

    PubMed 40112129

Questions about this trial

What is this clinical trial studying?

A study testing Robot-Assisted Telesurgery in people with Prostate Cancer and Colorectal Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.

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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. 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 BERNARDO B ROCCO, MD (+393358306522, bernardomariacesare.rocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion Rate from Remote to Local Robotic Surgery (%) (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07792109, which also lists 14 linked publications.

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 28 Aug 2026.

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GTSP Clinical Trial NCT07792109 | AzTrials