PainPhase 4NCT04029012
Penthrox in Rezūm BPH
A Phase 4 study testing Methoxyflurane in people with Pain and BPH, run by Dean Elterman at 1 site in Canada.
Trial summary
Open-labeled, single-centre study Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2019to 14 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Open-labeled, single-centre study
Read the 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.
- Being tested
- Methoxyflurane
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox
Methoxyflurane inhaler before Rezum procedure
| Study group | Role | What they receive |
|---|---|---|
| Penthrox | Experimental | methoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure. Receives: Drug: Methoxyflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual Analog Scale (VAS) from the range of 0-10 (0 represents no pain, 10 represents maximum pain)
Measured: immediately after final injection of Rezūm treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start10 Sep 2019
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dean Elterman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dean Elterman, Can-Am HIFU Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029012
- Sponsor's protocol ID
- Penthrox in Rezūm BPH
- Status last verified
- Jan 2022
- First submitted
- 19 Jul 2019
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04029012
- Acronym / sponsor ID
- Penthrox in Rezūm BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dean EltermanUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Penthrox | Experimental | Drug: Methoxyfluranemethoxyflurane inhaler (Penthrox) to be used 5 minutes (+/- 1 minutes) before procedure, and continuously breathing in the inhaler throughout the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethoxyfluraneAlso: PenthroxMethoxyflurane inhaler before Rezum procedure | Drug | Penthrox |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxyflurane in people with Pain and BPH, run by Dean Elterman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: immediately after final injection of Rezūm treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.