NCT06784986 Impact of Using the Airseal System With Ultra-low Pneumoperitoneum in Patients Undergoing Robot-assisted Radical Prostatectomy: A Prospective, Comparative, Randomized Clinical Study.
| NCT ID | NCT06784986 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Brazilian Institute of Robotic Surgery |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2025-02 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
NILO J. MD
PRINCIPAL INVESTIGATOR
Brazilian Institute of Robotic Surgery
Frequently Asked Questions
Who can join the NCT06784986 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 65 Years, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06784986 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06784986 currently recruiting?
Yes, NCT06784986 is actively recruiting participants. Contact the research team at ibcrpesquisa@gmail.com for enrollment information.
Where is the NCT06784986 trial being conducted?
This trial is being conducted at Salvador, Brazil, Salvador, Brazil.
Who is sponsoring the NCT06784986 clinical trial?
NCT06784986 is sponsored by Brazilian Institute of Robotic Surgery. The principal investigator is NILO J. MD at Brazilian Institute of Robotic Surgery. The trial plans to enroll 200 participants.