Can-Am HIFU Inc
Toronto, Ontario, Canada
NCT Number: NCT04029012
Open-labeled, single-centre study
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Notify Me18 year and older
Male
Interventional
Phase 4
Toronto, Ontario, Canada
Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Methoxyflurane inhaler before Rezum procedure
Other names: Penthrox
Time frame: immediately after final injection of Rezūm treatment
Visual Analog Scale (VAS) from the range of 0-10 (0 represents no pain, 10 represents maximum pain)
Dean Elterman
Other
A Pilot Study to Assess Efficacy and Safety of Methoxyflurane for Pain Control During Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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