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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | Men only |
| Enrollment | 200 (estimated) |
| Sponsor | Brazilian Institute of Robotic Surgery Academic / other |
| Locations | 2 sites (Salvador, Estado de Bahia and 1 other locations) |
| Status | Recruiting |
| Started | February 2025 |
| Main results expected | December 15, 2025 |
| Study ends | February 15, 2026 |
| Registry record updated | January 20, 2025 |
| Trial ID | NCT06784986 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
- Principal investigator: Nilo J. Md — Brazilian Institute of Robotic Surgery
- Study coordinator: Nilo Jorge Leão Coordenador
- Email: ibcrpesquisa@gmail.com
- Phone: +55 71 2626-3030
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.