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Penthrox in Rezūm BPH

Sponsor
Dean Elterman (Other)
Overall Status
Completed
CT.gov ID
NCT04029012
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
5.2
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open-labeled, single-centre study

Condition or Disease Intervention/Treatment Phase
Phase 4

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. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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)
Actual Study Start Date :
Sep 10, 2019
Actual Primary Completion Date :
Feb 14, 2020
Actual Study Completion Date :
Feb 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Penthrox

methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure.

Drug: Methoxyflurane
Methoxyflurane inhaler before Rezum procedure
Other Names:
  • Penthrox

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain intensity [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Can-Am HIFU Inc Toronto Ontario Canada

    Sponsors and Collaborators

    • Dean Elterman

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dean Elterman, Clinician Investigator/ Urologist, Can-Am HIFU Inc.
    ClinicalTrials.gov Identifier:
    NCT04029012
    Other Study ID Numbers:
    • Penthrox in Rezūm BPH
    First Posted:
    Jul 23, 2019
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Methoxyflurane

    Study Results

    No Results Posted as of Jan 24, 2022