Which gas pump causes less pain during robotic prostate surgery? a Head-to-Head trial

NCT ID NCT06915909

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Male participants only

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Lister hospital

    RECRUITING

    Stevenage, Hertfordshire, SG1 4AB, United Kingdom

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