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NCT06784986RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The AirSeal platform has been evaluated in urological surgeries, mainly in cases of malignant diseases 5,6. However, there is still a lack of data demonstrating the possible benefits of its use, which justifies the conduct of this research in order to aggregate such knowledge. Therefore, the objective of this prospective pilot study is to compare and evaluate the role of low-pressure pneumoperitoneum with the AirSeal system in patients with prostate cancer undergoing robot-assisted prostatectomy with those undergoing the procedure with the conventional insufflation system. We seek to provide more data on the use of AirSeal, which is associated with shorter operative times, shorter hospital stays and a lower probability of complications. In addition, we aim to ratify the effectiveness and cost-benefit of using the AirSeal system.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
200 (estimated)
First submitted
15 Jan 2025
Start date
Feb 2025
Primary completion date
15 Dec 2025
Lead sponsor
Brazilian Institute of Robotic Surgery
NCT number
NCT06784986

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 200
  • From Feb 2025 to the primary completion date, 15 Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients allergic to NSAIDs and/or Morphine and/or Tramadol;
  • Patients with chronic renal failure;

Age

  • Patients over 65 and under 18 years of age;

Other

  • Patients with recurrence, metastasis and other existing neoplasms.

Who the study is looking for

  • Patients with prostate cancer who will undergo robotic prostatectomy;

Age in the registry: 18 years to 65 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto Brasileiro de Cirurgia Robotica
Coordinator of this site? Confirm its status
SalvadorBrazilRecruiting
Hospital Mater Dei Salvador
Coordinator of this site? Confirm its status
SalvadorBrazilRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.