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Which gas pump causes less pain during robotic prostate surgery? a Head-to-Head trial
NCT ID NCT06915909
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This trial compares two devices that inflate the abdomen during robotic prostatectomy for prostate cancer: the AirSeal® Insufflation System and the Stryker PneumoClear Insufflator. The goal is to see which one leads to less pain during and after surgery. One hundred men scheduled for robotic prostatectomy will be randomly assigned to one of the two devices, and their pain, medication use, recovery time, and complications will be tracked for 30 days after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AirSeal® Insufflation System and Stryker PneumoClear Insufflator
- What this could lead to
- If one device clearly causes less pain, it could become the standard for robotic prostatectomies, making recovery more comfortable for many men.
- What could go wrong
- This is a small, early feasibility study (100 people) at a single hospital. Results may not apply to all patients or hospitals, and neither device may prove clearly better.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient indicated for non-emergent robotic Prostatectomy surgery * Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study * Males, aged 18 to 75 years * Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioural recommendations and office visits * Are American Society of Anaesthesiologists (ASA) Class I, II, or III); Exclusion Criteria: * Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor); * Patients requiring any surgical procedure in addition to Prostatectomy and or / Pelvic Lymph node dissection * Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity * Inability to provide informed consent * Unable or unwilling to attend follow-up visits and examinations * Uncontrolled hypertension (=/\>Systolic: 180 mmHg/Diastolic: 120 mmHg) and/or diabetes mellitus (Blood sugar level: \>200 mg/dL) * Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV * History of chronic alcohol or drug abuse within 2 years of the screening visit * Chronic renal failure or on dialysis * Significant complicating medical history or immunocompromised * History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma * Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders; * Any medical condition which precludes compliance with the study * Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and/or the soundness of this clinical study or which would contra-indicate a surgical procedure. * Previous or current history of being on regular analgesia / pain killers
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lister hospital
RECRUITINGStevenage, Hertfordshire, SG1 4AB, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A Multi-Centre, pivotal stage, study to determine the between MRI scanner reproducibility of gold standard phantom calibrated acquisition replicator (CARE) for measurement of apparent diffusion coefficients in the prostate of patients with MR positive lesions destined for biopsy
- A proactive care plan may help men with prostate cancer live better
- Can a simple blood test outsmart prostate cancer?
- Can a new tracer spot prostate cancer return better than the standard scan?
- Personalized prediction for Post-Prostatectomy erection recovery?
- A sharper eye on prostate cancer: could new imaging spare healthy tissue?