Status:
COMPLETED
Penthrox in Rezūm BPH
Lead Sponsor:
Dean Elterman
Conditions:
Pain
BPH
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Open-labeled, single-centre study
Detailed Description
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. Pa...
Eligibility Criteria
Inclusion
- Male subjects of ≥ 18 years of age
- Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia.
- No contra-indication on using Methoxyflurane inhaler (Penthrox™).
- Willing and able to accurately complete the required questionnaires.
- Willing and able to provide signed and dated informed consent.
Exclusion
- Ongoing use of analgesic agents for chronic pain.
- Concomitant use of nephrotoxic agents.
- INR \> 4.
- Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months.
- Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel.
- Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics.
- Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment.
- An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol.
- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
- A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04029012
Start Date
September 10 2019
End Date
February 14 2020
Last Update
January 24 2022
Active Locations (1)
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1
Can-Am HIFU Inc
Toronto, Ontario, Canada