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NCT04029012 Clinical Trial

Penthrox in Rezūm BPH

Pain Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04029012
Other study ID # Penthrox in Rezum BPH
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 10, 2019
Est. completion date February 14, 2020

Study information
Verified date January 2022
Source Can-Am HIFU Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-labeled, single-centre study

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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 14, 2020
Est. primary completion date February 14, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male subjects of = 18 years of age - Patient who has elected Convective Thermal Therapy using Rezum 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 Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methoxyflurane
Methoxyflurane inhaler before Rezum procedure

Locations
Country Name City State
Canada Can-Am HIFU Inc Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Dean Elterman

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain intensity Visual Analog Scale (VAS) from the range of 0-10 (0 represents no pain, 10 represents maximum pain) immediately after final injection of Rezum treatment
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