Clinical trial Recruiting at 2 sites Phase 4 Interventional Ages 18 to 65 Men only

Using the AirSeal System for Robot-assisted Prostate Surgery

Official title: Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.

Run by Brazilian Institute of Robotic Surgery · NCT06784986 · Data updated 2026-11-12

This study tests if using the AirSeal system during robot-assisted prostate surgery can lead to better results, like shorter hospital stays and fewer complications, for men with prostate cancer compared to traditional methods.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 65 Years
SexMen only
Enrollment200 (estimated)
SponsorBrazilian Institute of Robotic Surgery
Academic / other
Locations2 sites (Salvador, Estado de Bahia and 1 other locations)
StatusRecruiting
StartedFebruary 2025
Main results expectedDecember 15, 2025
Study endsFebruary 15, 2026
Registry record updatedJanuary 20, 2025
Trial IDNCT06784986 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with prostate cancer who are scheduled for robotic prostatectomy.

Probably not a fit

Patients over 65 years old, under 18 years old, or those with chronic renal failure or other existing neoplasms may not benefit from this study.

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

What this trial studies

This clinical trial evaluates the effectiveness of the AirSeal system in providing low-pressure pneumoperitoneum during robot-assisted radical prostatectomy for patients with prostate cancer. The study compares outcomes between patients using the AirSeal system and those using conventional insufflation methods. It aims to gather data on operative times, hospital stays, and complication rates associated with the AirSeal system. The research seeks to establish the cost-benefit and overall effectiveness of this innovative surgical approach.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for prostate cancer patients undergoing robotic surgery.

How similar studies have gone: Preliminary studies have shown promise for the AirSeal system in urological surgeries, suggesting potential benefits, though this specific approach is still being evaluated.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with prostate cancer who will undergo robotic prostatectomy;

Exclusion Criteria:

* Patients over 65 and under 18 years of age;
* Patients allergic to NSAIDs and/or Morphine and/or Tramadol;
* Patients with chronic renal failure;
* Patients with recurrence, metastasis and other existing neoplasms.

Where it's running

  • Instituto Brasileiro de Cirurgia Robotica
    Salvador, Estado de Bahia, Brazil
    Recruiting
  • Hospital Mater Dei Salvador
    Salvador, Estado de Bahia, Brazil
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.