- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04029012
Penthrox in Rezūm BPH
January 7, 2022 updated by: Dean Elterman
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)
Open-labeled, single-centre study
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Can-Am HIFU Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Methoxyflurane inhaler before Rezum procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
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)
|
immediately after final injection of Rezūm treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2019
Primary Completion (Actual)
February 14, 2020
Study Completion (Actual)
February 14, 2020
Study Registration Dates
First Submitted
July 19, 2019
First Submitted That Met QC Criteria
July 22, 2019
First Posted (Actual)
July 23, 2019
Study Record Updates
Last Update Posted (Actual)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 7, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Penthrox in Rezūm BPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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