Benign Prostatic HyperplasiaWT-DK-TMW08NCT00662350
Temperature Mapping of the Prostate With the Wallterm™ System
An observational study of Benign Prostatic Hyperplasia, run by Pnn Medical A/S at 1 site in Denmark.
Trial summary
To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions achieved under the standard treatment protocol in men with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- The Wallterm™ System
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2008to Aug 2009
- Phase
- Observational
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with BPH
Who may be able to join
- Men with symptomatic BPH requiring treatment,
- IPSS score > 15
- Age > 50 years
- Prostate size of 25 g or greater
- Prostatic urethra length between 2.0 cm and 5.5 cm,
- Ability to understand and consent to participate in this investigation,
- Willingness and ability to participate in all required follow-up evaluations.
Who cannot join
- Allergy towards Silicone,
- Peak Urinary Flow > 15 mL/s,
- Penile or urinary sphincter implant,
- Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.)
- Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,
- Evidence of a non-symmetric prostatic median lobe enlargement, or a prostatic lobe which is prominent with an obstructing "ball valve", as determined by cystoscopy or ultrasound,
Show all 19Show fewer
- Patients with any previous prostate surgery, procedure for BPH, or any other invasive treatment to the prostate (such as TUR-P).
- Previous rectal surgery (Exception: hemorrhoid surgery), radical pelvic surgery or pelvic irradiation.
- Patients with confirmed or suspected bladder cancer.
- Patients with a history of cystolithiasis or bladder pathology, or who have experienced relapsing bacterial prostatitis within the last 6 months.
- Patients with gross haematuria. (Note: These patients may be eligible for this investigation if the results of a careful workup for cancer, including an X-ray study, cystoscopy and cytology, are found to be negative.)
- Patients with a history of bladder neck contracture.
- Patients who presently have urethral strictures, which prevent the passage of a 20 Fr endoscope (these patients may be treated after successful treatment of the stricture).
- Patients with neurogenic bladder dysfunction (neurogenic detrusor hypo- or hyperactivity).
- Patients interested in future fertility.
- Patients who have chronic catheter drainage due to urinary retention (these patients may be treated if a CMG demonstrates that the patient has a contractile bladder).
- Patients with bleeding disorders, or other systemic disorder contraindication minimally invasive surgical therapies.
- Any condition (ie: vascular clips) which would preclude an MRI from being performed, or otherwise confound this investigation.
- Patients with compromised renal function (i.e. serum creatinine >150 mls/l), renal or upper tract dilatation.
Trial locations and contacts
1 site in 1 country.
About this study
To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions achieved under the standard treatment protocol in men with benign prostatic hyperplasia (BPH).
Read the detailed description
The Wallterm System provides minimally invasive treatment of benign prostatic hyperplasia (BPH) via a high temperature, liquid filled, balloon thermotherapy. The catheter is composed of a silicone positioning balloon which anchors the catheter against the bladder neck. The multi-layer silicone treatment balloon may be adjusted to fit short (20-35mm) and long (40-55mm) prostates and is inflated (to approximately 650-700 mmHg / 20-22mm diameter) to ensure tight tissue contact and reduced blood perfusion. The handle contains the heating element and the liquid circulation mechanisms
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- The Wallterm™ System
- Keywords
- BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Wallterm™ SystemDevice
Also called Wallterm™ Catheter (model 3010), Wallterm™ Central Unit (model 3020-10)
The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH).
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic Benign Protate Hypertrophy | Symptom Score (IPSS) greater than 15, requiring invasive treatment, Prostate size greater than 25 g, Prostatic urethra length between 2.0 cm and 5.5 cm Receives: Device: The Wallterm™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the temperatures within the prostate using the Wallterm System
Measured: Assessed at primary treatment
Secondary outcomes (2)
To assess whether the Wallterm System delivers safe and consistent temperatures from base to apex; and determine the temperature range toward rectum, along the urethra.
Measured: Immediate
Delineate the extent and the location of necrosis
Measured: Short term
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pnn Medical A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jørgen Nordling, Professor, Principal investigator, Urological Dep., Herlev Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662350
- Sponsor's protocol ID
- WT-DK-TMW08
- Acronym
- WT-DK-TMW08
- Status last verified
- Feb 2010
- First submitted
- 7 Apr 2008
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Mapping of the Prostate With the Wallterm™ System
- ClinicalTrials.gov ID
- NCT00662350
- Acronym / sponsor ID
- WT-DK-TMW08 / WT-DK-TMW08
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Pnn Medical A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 21 Apr 2008 (estimated)
- 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.
To measure intra-prostatic temperatures and evaluate the shape and size of necrotic lesions achieved under the standard treatment protocol in men with benign prostatic hyperplasia (BPH).
Detailed description
The Wallterm System provides minimally invasive treatment of benign prostatic hyperplasia (BPH) via a high temperature, liquid filled, balloon thermotherapy. The catheter is composed of a silicone positioning balloon which anchors the catheter against the bladder neck. The multi-layer silicone treatment balloon may be adjusted to fit short (20-35mm) and long (40-55mm) prostates and is inflated (to approximately 650-700 mmHg / 20-22mm diameter) to ensure tight tissue contact and reduced blood perfusion. The handle contains the heating element and the liquid circulation mechanisms
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic Benign Protate Hypertrophy | – | Device: The Wallterm™ SystemSymptom Score (IPSS) greater than 15, requiring invasive treatment, Prostate size greater than 25 g, Prostatic urethra length between 2.0 cm and 5.5 cm |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with BPH
Key inclusion criteria (7 listed)
- Men with symptomatic BPH requiring treatment,
- IPSS score > 15
- Age > 50 years
- Prostate size of 25 g or greater
- Prostatic urethra length between 2.0 cm and 5.5 cm,
Key exclusion criteria (19 listed)
- Allergy towards Silicone,
- Peak Urinary Flow > 15 mL/s,
- Penile or urinary sphincter implant,
- Patients with active urinary tract infection indicated by a positive urinary culture >105 CFU (Note: These patients may be treated after successful treatment of the infection.)
- Clinical (historical), paraclinical (i.e. PSA> 10ng/mL) or histological evidence of prostatic cancer or bladder cancer,
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 |
|---|---|---|
| The Wallterm™ SystemAlso: Wallterm™ Catheter (model 3010), Wallterm™ Central Unit (model 3020-10)The Wallterm™ System is intended to ablate prostatic glandular and stromal tissue to relieve moderate to severe symptoms of outflow obstruction secondary to benign prostatic hyperplasia (BPH). | Device | Symptomatic Benign Protate Hypertrophy |
Primary outcome
To assess the temperatures within the prostate using the Wallterm System
Time frame: Assessed at primary treatment
2 secondary outcomes
To assess whether the Wallterm System delivers safe and consistent temperatures from base to apex; and determine the temperature range toward rectum, along the urethra.
Time frame: Immediate
Delineate the extent and the location of necrosis
Time frame: Short term
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 4 Feb 2010.
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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.
Jørgen Nordling, Professor principal investigator
Urological Dep., Herlev Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by Pnn Medical A/S at 1 site in Denmark.
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 7 inclusion and 19 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 4 Feb 2010. 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 Denmark. 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.
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?
To assess the temperatures within the prostate using the Wallterm System (time frame: Assessed at primary 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 4 Feb 2010.